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Pfizer to Merge Its Off-Patent Drug Unit With Mylan

By: Annual-Meeting | August 20, 2019 | 212 view(s)

Pfizer agreed on Monday to combine its off-patent drugs division, which sells treatments like the cholesterol drug Lipitor, with the pharmaceutical company Mylan, creating a potential powerhouse in the increasingly challenging business of producing generic medicines. The deal follows years of consolidation in the generic-drug industry and could spur more acquisitions, as companies struggle to maintain sales amid falling prices for their products. It’s a development that has been largely overlooked as consumers grapple with the escalating cost of branded treatments. Pfizer’s decision to combine the off-patent unit, Upjohn, with Mylan in an all-stock deal coincides with the pharmaceutical giant’s narrowing of its focus on more profitable, branded drugs. Though Mylan mainly produces generic drugs, it is best known for its EpiPen emergency allergy treatment. The shift has led Pfizer to acquire promising new drugs through big deals like its $10.6 billion takeover bid last month for Array BioPharma, which makes specialized cancer treatments. Along the way, Pfizer has unloaded lower-margin businesses, as it did last year by agreeing to combine its consumer health care division with a similar unit owned by GlaxoSmithKline.   Pfizer used Upjohn to package older products like Lipitor and the erectile dysfunction drug Viagra — whose patents have expired or are about to — with its generics business. Sales of those drugs have plummeted in the United States, but Pfizer hoped Upjohn would be able to capitalize on the growing market for so-called branded generics in countries like China, where low-quality and even fraudulent generic drugs proliferate and consumers seek out brands like Pfizer as a guarantee of quality. Pfizer even moved Upjohn’s headquarters to Shanghai this year. But the creation of Upjohn as a stand-alone unit also prompted questions about whether Pfizer’s ultimate plan was to spin it off. In April, Albert Bourla, the company’s chief executive, told analysts that he might make such a move one day, “but this is not what is in my mind right now.”   The combined business, which will eventually be renamed, is expected to have about $19 billion to $20 billion in annual sales. The companies anticipate annual savings of $1 billion by 2023 as a result of the deal. “We are creating a new champion for global health — one poised to bring world-class medicines to patients across a wide range of therapeutic areas,” Mr. Bourla said in a statement. Mylan, whose stock price is down about 30 percent this year, has faced a series of controversies in recent years, including the skyrocketing price of the EpiPen and a continuing federal inquiry into price-fixing in the generic drug industry. Heather Bresch, Mylan’s chief executive, will relinquish that role. Ms. Bresch, whose father is Senator Joe Manchin III, Democrat of West Virginia, spent nearly her entire career at Mylan and became chief executive in 2012. She drew public outrage in 2016 when it emerged that her compensation had increased even as the price of the EpiPen soared. She was among the first in the industry to try to pin the blame for rising drug prices on rebates paid to pharmacy-benefit managers. In 2014, she and other executives angered many shareholders by moving their headquarters to the Netherlands from Pennsylvania to reap tax savings and to block a takeover by Teva that many investors favored. Ms. Bresch, who declined to comment on Monday, will be succeeded by the head of Upjohn, Michael Goettler. The generic industry’s struggles extend well beyond Mylan. Fewer blockbuster drugs are losing their patent protection, depriving makers of generics the chance to capitalize on the lucrative period immediately after a patent expires. Pharmacies and wholesalers are making things more difficult by teaming up to increase their ability to bargain for lower prices. That has forced makers of generic drugs to consider mergers as a way of regaining leverage. Last fall, Novartis sold portions of its generic unit, Sandoz, to Aurobindo Pharma, and in 2016, the generics maker Teva acquired Allergan’s Actavis generics business. The Actavis acquisition has not solved Teva’s challenges, and the company has continued to struggle. David Maris, an analyst at Wells Fargo, cited the Teva deal in a note on Monday that signaled caution about the prospects for the combination of Upjohn and Mylan. “The combined company is bigger, but we are not sure it is better, and integration risks are not minimal, in our view,” he wrote. The transaction is expected to close by the middle of next year, pending the approval of regulators and Mylan shareholders. Pfizer shares were down nearly 3 percent on Monday, closing at $41.45. Mylan shares were up more than 12 percent, at $20.78.   Follow Michael J. de la Merced and Katie Thomas on Twitter: @m_delamerced and @katie_thomas.

In a Disease of Aging, Patients in Trials Get Younger and Younger

By: Annual-Meeting | August 20, 2019 | 166 view(s)

Cancer is a disease of aging, but the median age of participants in clinical trials of oncologic treatments keeps getting younger, according to a new analysis. The age disparities between cancer patients in clinical trials and their real-world counterparts with the same tumor types are "pervasive and worsening," say the study authors, led by Ethan Ludmir, MD, University of Texas MD Anderson Cancer Center in Houston. The findings come from a meta-analysis of 302 clinical trials with 262,354 participants enrolled between 1994 and 2015. The median age of these participants was 6.49 years younger (P < .001) than the median age of real-world patients with the same cancers in a federal database. That's a "substantial difference," the authors comment.   Further, the investigators' analysis also revealed an apparent "widening gap" between trial patients' and real-world patients' median ages over time — at a rate of −0.19 years annually (P = .04). In short, clinical trial patients are getting younger and younger compared with real-world patients. Younger patients are desirable because, as a group, they can better tolerate toxicities and adverse events than older patients, which could determine a trial's success or failure. The study was published online June 3 in JAMA Oncology. However, clinicians should not be deterred by any of this, said Ludmir in an email to Medscape Medical News. "The message we'd like to give fellow oncologists: don't let age alone be the reason a patient is not offered an opportunity to participate in a clinical trial," he commented. Ludmir also emphasized that cancer patients, as a demographic, are getting older and should be assessed by their functionality and other factors for trial participation. "By 2030, 70% of all new cancer diagnoses will be among patients aged 65 and over," he said. The study authors point out that older cancer patients have long been underrepresented in clinical trials, a fact first established 15-20 years ago in an analysis of National Cancer Institute (NCI) funded trials. The investigators wondered: has this age problem persisted in more modern settings, including for new targeted therapies and among industry-sponsored trials?   And so they looked at clinical trials of treatments for the four most common cancers (breast, prostate, colorectal, and lung) and compared the median age of participants versus the median age of same-tumor patients at diagnosis in the NCI Surveillance, Epidemiology and End Results (SEER) database.   In other words, they compared the median ages of cancer patients from the universe of randomized clinical trials (RCTs) with those of the real-world population. The RCTs included systemic drugs (n = 247), radiation (n = 7), surgery (n = 2), and supportive care (n = 45).   "We hope this paper encourages self-reflection and conscientious attention to age inclusion for clinical trials," said senior author C. David Fuller, MD, also from MD Anderson.   "Older adults with cancer continue to be vastly underrepresented in cancer clinical trial participation," summarized Beverly Moy, MD, MPH, Massachusetts General Hospital (MGH) Cancer Center, Boston, who was asked for comment.   It would be clarifying if trialists called out this shortcoming, said Bishal Gyawali, MD, PhD, Queens University, Kingston, Ontario, Canada, who was also invited to comment.   I don't remember ever seeing a trial publication that has discussed the age of trial participants as a limitation.    Bishal Gyawali, MD, PhD   "I don't remember ever seeing a trial publication that has discussed the age of trial participants as a limitation," he said. "No trial has ever mentioned that 'the participants in our trial were younger and fitter than the routine patients with this cancer and thus may not be representative of real-world outcomes.'"   Medscape Medical News passed along Gyawali's quote to MD Anderson's Fuller, who responded: "I agree with the comment!"   Trialists may ignore this question of the applicability of their RCT results, but other oncologists are taking notice, suggested Gyawali.   "That RCTs include fitter patients, exclude elderly patients, and thus are not representative of real-world patients, is an acknowledged problem in oncology. For this reason, ASCO has also recently issued a guideline recommending wider inclusion of elderly patients in cancer RCTs," he said.   MGH's Moy echoed some of these comments: "There has been a movement from the entire oncology community, especially the geriatric oncology community, to call attention to this issue [of underrepresentation of older patients]."   The study authors suggest it may be time to add age to the list of disparities such as sex, race/ethnicity, and socioeconomics that commonly limit the findings of clinical trials in oncology.   Nonetheless, Moy reminded that there are various "barriers" to enrolling older cancer patients in trials, including financial barriers that arise out of problems with insurance in the United States, particularly Medicare.   A Novel Finding The investigators report that the majority of the trials (n = 247, 82.5%) in their review were industry-funded. About three quarters of the trials were multinational.   The investigators found that age disparities were greater among industry-funded trials compared with nonindustry-funded trials (mean difference in median age, −6.84 vs −4.72 years; P = .002).   This is a novel finding, say the authors. "No prior studies have demonstrated demographic disparities among [cancer clinical] trial participants as a function of industry funding," they write.   Notably, most of the clinical trials (n = 276) did not have enrollment criteria that restricted access based on age. Only 26 trials had such age restrictions.   However, the investigators report that enrollment criteria restrictions — based on performance status or age cutoffs — were associated with age disparities.  Nonetheless, industry-funded trials were "not more likely to use these enrollment restrictions than nonindustry-funded trials," observe the authors.     Age disparities were also larger among trials that evaluated a targeted systemic therapy (ie, monoclonal antibody or small molecule inhibitor) compared with those that tested cytotoxic chemotherapy (−7.72 vs −5.30 years; P = .01).   In the current study, the investigators cannot identify exactly how clinical trial participants ended up being much younger than real-world cancer patients, but the authors believe it is an important matter to address.   "With an increasing role of industry funding among cancer trials, efforts to understand and address age disparities are necessary to ensure generalizability of trial results as well as equity in trial access," they conclude.   Disclosures for the authors are listed in the article. Gwayali and Moy have reported no relevant financial relationships.   JAMA Oncol. Published online June 3, 2019. Abstract   Follow Medscape's Nick Mulcahy on Twitter. For more from Medscape Oncology, join us on Twitter and Facebook.

Diagnosed ovarian cancer cases set to reach 66,000 across seven major markets in 2028, says GlobalData

By: Annual-Meeting | August 20, 2019 | 171 view(s)

The diagnosed incident cases of ovarian cancer in the seven major markets (7MM*) will increase at an annual growth rate (AGR) of 0.42% from over 63,000 cases in 2018 to 66,000 cases in 2028. All countries in the 7MM, except the US, will see a slight increase in diagnosed incident cases through the forecast period, according to GlobalData, a leading data and analytics company. The company’s report: ‘Ovarian Cancer: Epidemiology Forecast to 2028’ found that in 2018, the US had the highest number of diagnosed incident and diagnosed prevalent cases of ovarian cancer. However, the US is the only market that will see a decrease in cases at a negative AGR of 0.22% during the forecast period. Nanthida Nanthavong, Epidemiologist at GlobalData, comments: “The decrease in incident cases in the US is due to an expected decrease in incidence rate during the forecast period for women ages 50 years and older, which can be attributed to decreased usage of menopausal hormones and increased usage of oral contraceptives, as well as changes in population. In the European markets and Japan, incidence will remain largely unchanged over the forecast period.” Image for publication: Please click here for enlarged chart Across all markets, diagnosing ovarian cancer continues to be difficult because symptoms can be non-specific and vague, resulting in a late diagnosis when the disease is in advanced stages. Nanthavong concludes: “The ability to detect ovarian cancer at an early stage is a research priority, as patients diagnosed at an early stage are estimated to have a significantly higher five-year survival rate than patients with a late-stage diagnosis.” *7MM: US, France, Germany, Italy, Spain, UK, and Japan. ENDSFor more information To gain access to our latest press releases: GlobalData Media Centre Analysts available for comment. Please contact the GlobalData Press Office:EMEA & Americas: +44 (0)207 832 4399Asia-Pacific: +91 40 6616 6809 Email: For expert analysis on developments in your industry, please connect with us on: GlobalData | LinkedIn | Twitter Notes to Editors Quotes provided by Nanthida Nanthavong, Epidemiologist at GlobalData Information based on GlobalData’s report: Ovarian Cancer: Epidemiology Forecast to 2028 About GlobalData4,000 of the world’s largest companies, including over 70% of FTSE 100 and 60% of Fortune 100 companies, make more timely and better business decisions thanks to GlobalData’s unique data, expert analysis and innovative solutions, all in one platform. GlobalData’s mission is to help our clients decode the future to be more successful and innovative across a range of industries, including the healthcare, consumer, retail, financial, technology and professional services sectors.  If you would rather not receive future communications from GlobalData, let us know by clicking here.GlobalData, John Carpenter House 7 Carmelite Street, London, N/A EC4Y 0BS United Kingdom

Having a Parent, Sibling, or Child with Blood Cancer Increases One’s Own Risk

By: Annual-Meeting | August 16, 2019 | 162 view(s)

Data from largest population study to date help identify at-risk individuals, could inform screening initiatives Published on: August 08, 2019 (WASHINGTON, August 8, 2019) — New data suggest that people who have a parent, sibling, or child with blood cancer have a higher likelihood of being diagnosed with the disease. The study published online today in Blood offers the first evidence that such familial risks exist across the spectrum of hematologic malignancies. Age of diagnosis, whether the relative is a parent, sibling, or child, and the number of affected first-degree relatives play a defining role in the relative risk of developing certain blood cancers, according to the study. “This information improves our understanding of the causes of – and potential inherited predisposition to – blood cancers and should inform the identification and characterization of genetic risk factors for blood cancer, as well as how we best clinically manage patients and their relatives,” said Amit Sud, MD, PhD, of The Institute of Cancer Research, London, and the study’s lead author. “The results should also encourage conversations among families, clinicians, and patients about familial risk.” While earlier studies have demonstrated the increased risk of blood cancers in first-degree relatives of affected individuals, this is the largest and most comprehensive population-based evaluation to date. Cases with a familial link represented 4.1 percent of all blood cancer diagnoses – higher than cancers of the nervous system, kidney and pancreas, but lower than those of the breast, colorectum, and prostate, which range from 8 to 15 percent, researchers report. Highest relative risks were seen for certain Hodgkin lymphoma (HL) subtypes, lymphoplasmacytic lymphoma, and mantle cell lymphoma. Markedly elevated familial risks were also observed for polycythemia vera, myelodysplasia and essential thrombocythemia.  While there are currently no definitive screening initiatives for blood cancers, a 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia recognized familial disease as an essential component of diagnosing certain subsets of blood cancers and underscores the need to further examine and understand familial risk. Developing definitive screening protocols based on evidence is an emerging area of research. “We hope these robust data will be used to inform guidelines on genetic testing and screening. Certainly there are a number of individuals, such as those with a relative diagnosed at a young age and or with more than one affected first-degree relatives, for whom counseling, genetic testing, and surveillance may be appropriate,” Dr. Sud said.  The present analysis drew from 16 million people in the Swedish Family-Cancer Database, ultimately including 153,115 patients with a confirmed blood cancer and 391,131 first-degree relatives, which allowed Dr. Sud and colleagues to fully characterize familial risk across all blood cancer types. For specific blood cancers such as chronic lymphocytic leukemia (CLL), the increase in risk is dependent on the age of the affected relative; whether it is a parent, sibling, or child; and the number of affected first-degree relatives. For example, for non-Hodgkin lymphoma, HL, and CLL, the risk was higher among those who had a sibling with the disease, whereas others blood cancers were more likely to occur if a parent had been diagnosed. Generally, the familial risk was more pronounced when relatives were diagnosed at younger ages. Dr. Sud added that the analysis also has potential implications for the selection of related stem-cell donors used for the treatment of these malignancies. In addition to its size and long follow-up, another strength of the analysis is its use of registry data for which almost all blood cancer cases in the Swedish population had been recorded. Still, researchers say the findings may not be applicable to economically developing countries that tend to have different tumor incidence rates and potentially different environmental and genetic risk factors. The study was conducted as a collaboration between European research institutes: The Institute of Cancer Research in London, the German Cancer Research Centre in Heidelberg, and Lund University in Sweden. Blood (, the most cited peer-reviewed publication in the field of hematology, is available weekly in print and online. Blood is a journal of the American Society of Hematology (ASH) (, the world’s largest professional society concerned with the causes and treatment of blood disorders. Contact:Leah Enser, American Society of; 202-552-4927

Roswell Park Researchers Identify Immune Biomarker of Response in Patients With Advanced Liver Cancer

By: Annual-Meeting | August 15, 2019 | 130 view(s)

Findings may guide decisions about which patients will benefit most from treatment with sorafenib Advanced hepatocellular carcinoma (HCC) is commonly treated with sorafenib Subset of CD8+ cells are biomarker linked with survival benefit, team shows Evidence could lead to more individualized treatments for liver cancer patients  BUFFALO, N.Y. — Roswell Park Comprehensive Cancer Center immunology researchers have uncovered a biomarker that may help explain why some patients respond better than others to a common chemotherapy treatment for liver cancer. They hope that their analysis of immune responses among patients receiving sorafenib can lead to more individualized treatment options and better overall outcomes for patients diagnosed with the disease. Dr. Yasmin Thanavala and team found that elevated levels of a subset of cytotoxic CD8+ T cells were a good biomarker of survival for patients taking sorafenib for liver cancer. The 4-year study, led by Department of Immunology scientist Yasmin Thanavala, PhD, was published online this week in JCI Insight, a peer-reviewed journal published by the American Society for Clinical Investigation, and also to be highlighted in the journal’s JCI This Month digest for September 2019. Hepatocellular carcinoma (HCC), which can arise from liver cirrhosis, is the most common form of liver cancer. The mainstay oral chemotherapy treatment for patients with advanced HCC is sorafenib — but side effects from this drug may cause many patients to miss doses or discontinue treatment. The researchers, who included Renuka Iyer, MD, Section Chief for Gastrointestinal Oncology at Roswell Park, collected blood samples from 30 patients both before treatment and at two timepoints during treatment with sorafenib. They observed elevated levels of a subset of CD8+ cytotoxic T-cells (CD8+ Ki67+ T cells producing IFN?? producing interferon type II, an important immune protein that destroys tumor cells and significantly reduces risk of death over time. Similarly, CD8+ cells showed an increase in granzyme B, an important enzyme that helps drive cell death. Additional findings showed that patients with a high ratio of CD4+ T-effector/T-regulatory cells prior to treatment showed significant improvement in both progression-free and overall survival. Decreased numbers of two important immune checkpoint proteins expressed on T-cells — PD-1 and CTLA-1 — suggests that a combination treatment of sorafenib with checkpoint inhibitors such as nivolumab and pembrolizumab could produce positive results in the future. “Studying biomarkers that correlate with progression-free or overall survival can help reduce exposure to therapies that have an impact on a patient’s quality of life and survival,” says Dr. Thanavala, who led this research. “Utilizing this information, our evidence supports the rationale that patients could benefit from a regimen of sorafenib and immunotherapy, which could help with antitumor immunity and improve the magnitude and strength of antitumor responses.” The study, “Augmentation of IFN-y+ CD8+ T cell responses correlates with survival of HCC patients on sorafenib therapy,” is available at This work was supported by the National Cancer Institute, or NCI (grant P30CA016056), the National Comprehensive Cancer Network® (NCCN®) Oncology Research Program from general research support provided by Bayer U.S LLC (NCCNSORA0002), and by donations to Roswell Park. ### For an online version of this release, please visit: Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at, or contact us at 1-800-ROSWELL (1-800-767-9355) or   If you would rather not receive future communications from Roswell Park Comprehensive Cancer Center, let us know by clicking here.Roswell Park Comprehensive Cancer Center, Elm And Carlton St, Buffalo, NY 14263-0001 United States


By: Annual-Meeting | August 15, 2019 | 184 view(s)

TAGRISSO is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous system metastases lived without disease progression   (WILMINGTON, Del., August 9, 2019) AstraZeneca today announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomized, double-blinded, multicenter trial of TAGRISSO in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations.   TAGRISSO showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care (SoC) treatments in this setting. The FLAURA trial met its primary endpoint in July 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death from any cause. The safety and tolerability of TAGRISSO was consistent with its established profile.   José Baselga, Executive Vice President, Oncology R&D said: “Today’s positive results show that TAGRISSO provides an unprecedented survivaloutcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors, reaffirming TAGRISSO as the 1st-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer.”   AstraZeneca plans to present the OS results from the FLAURA trial at a forthcoming medical meeting.   TAGRISSO is currently approved in more than 74 countries, including the US, Japan and the EU, for 1st-line EGFR-mutated metastatic NSCLC.   TAGRISSO IMPORTANT SAFETY INFORMATION   TAGRISSO may cause serious side effects, including:   lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded eye problems. TAGRISSO may cause eye problems. Tell your doctor right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your doctor may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO   Before taking TAGRISSO, tell your doctor about all of your medical conditions, including if you: have lung or breathing problems have heart problems, including a condition called long QTc syndrome have problems with your electrolytes, such as sodium, potassium, calcium or magnesium have a history of eye problems are pregnant or plan to become pregnant. TAGRISSO can harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant o        Females who are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 6 weeks after the final dose of TAGRISSO o        Males who have female partners that are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 4 months after the final dose of TAGRISSO are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during treatment with TAGRISSO and for 2 weeks after your final dose of TAGRISSO. Talk to your doctor about the best way to feed your baby during this time   Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine   The most common side effects of TAGRISSO are: diarrhea rash dry skin changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails mouth sores tiredness decreased appetite   Tell your doctor if you have any side effect that bothers you or that does not go away.   These are not all the possible side effects of TAGRISSO. For more information, ask your doctor or pharmacist.   Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   What is TAGRISSO? TAGRISSO is a prescription medicine for non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). TAGRISSO is used: as a first treatment if tumors have a certain abnormal epidermal growth factor receptor (EGFR) gene(s) or for a certain type of EGFR gene that has been treated with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working   Your doctor will perform a test to make sure that TAGRISSO is right for you.   It is not known if TAGRISSO is safe and effective in children.   Please see full Prescribing Information including Patient Information.   NOTES TO EDITORS   About lung cancer Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined.1 Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% classified as NSCLC.2 Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated (EGFRm) NSCLC.3-5 These patients are particularly sensitive to treatment with EGFR TKIs which block the cell-signaling pathways that drive the growth of tumor cells. Approximately 25% of patients with EGFR-mutated NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis.6 The presence of brain metastases often reduces median survival to less than eight months.7   About TAGRISSO TAGRISSO (osimertinib) is a third-generation, irreversible EGFR TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases. TAGRISSO 40mg and 80mg once-daily oral tablets have now received approval in more than 70 countries, including the US, Japan, and the EU, for 1st-line EGFR-mutated advanced NSCLC, and in more than 80countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC. TAGRISSO is also being developed in the adjuvant setting (ADAURA trial), in the locally-advanced unresectable setting (LAURA), in combination with chemotherapy (FLAURA2) and in combination with potential new medicines (SAVANNAH, ORCHARD).   About FLAURA The FLAURA trial assessed the efficacy and safety of TAGRISSO 80mg orally once daily vs. comparator EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC. The trial was double-blinded and randomized, with 556 patients across 29 countries.   About AstraZeneca in lung cancer AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease, lines of therapy and modes of action. We aim to address the unmet needs of patients with EGFR-mutated tumors as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines gefitinib and TAGRISSO, and ongoing Phase III trials FLAURA, FLAURA2, ADAURA and LAURA as well as the Phase III exploratory combination trials SAVANNAH and ORCHARD.   Our extensive late-stage Immuno-Oncology program focuses on lung cancer patients without a known genetic mutation which represents up to 50% of all patients with lung cancer. Durvalumab, an anti-PDL1 antibody, is in development as monotherapy (Phase III trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5, and PEARL) and in combination with tremelimumab and/or chemotherapy (AEGEAN, PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN Phase III trials).   About AstraZeneca in oncology AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in hematology.   By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.   About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit and follow us on Twitter @AstraZeneca.   CONTACTS   Media Inquiries US Media Line                                    +1 302 885 2677

Add-On Chemo Boosts Survival in High-Risk Endometrial Cancer

By: Annual-Meeting | August 15, 2019 | 120 view(s)

Adjuvant chemoradiotherapy improved overall survival for women with locally advanced endometrial cancer compared with radiation alone, a post-hoc analysis of the phase III PORTEC-3 trial found. With adjustment for stratification factors, overall survival (OS) at 5 years was 81.4% in the chemoradiotherapy group compared with 76.1% in the group receiving radiotherapy alone (adjusted HR 0.70, 95% CI 0.51-0.97, P=0.034), reported Stephanie de Boer, MD, of Leiden University Medical Center in the Netherlands, and colleagues.   And in their study of over 600 patients with stage I-III endometrial cancer, failure-free survival (FFS) at 5 years was 76.5% with chemoradiotherapy versus 69.1% with radiation alone (HR 0.70, 95% CI 0.52-0.94, P=0.016). "These updated results of the PORTEC-3 trial, with a longer median follow-up of 72 months and with 75% of participants having reached 5 years of follow-up, showed a significant improvement in both overall and failure-free survival with chemoradiotherapy versus radiotherapy alone for high-risk endometrial cancer," they wrote in the Lancet Oncology. For first site of recurrence, distant metastases were the most common, with a 5-year probability of 21.4% versus 29.1% for the chemoradiotherapy and radiation-alone groups, respectively (HR 0.74, 95% CI 0.55-0.99, P=0.047). Isolated pelvic and vaginal recurrences were rare, with no significant differences seen between groups. "In the aftermath of these potentially practice-changing results, additional questions are raised," Marcus Randall, MD, of the University of Kentucky in Lexington, wrote in an accompanying editorial. Do the findings apply to all subgroups? Would chemotherapy alone be sufficient in the adjuvant setting? Is there a "preferred way" to combine chemotherapy with radiation? "Taking into account the statistical limitations of subgroup analyses," he said, "the therapeutic benefit of combined chemotherapy and radiotherapy (vs radiotherapy alone) appeared to remain confined to patients with stage III disease and those with serous carcinomas of all stages."   For the stage III patients, 5-year OS and FFS were both significantly improved for the chemoradiotherapy group versus radiation-alone group: OS: 78.5% vs 68.5% (HR 0.63, 95% CI 0.41-0.99, P=0.043) FFS: 70.9% vs 58.4% (HR 0.61, 95% CI 0.42-0.89, P=0.011)   For stage I-II disease, survival outcomes modestly favored the combined adjuvant treatment numerically, but neither of the differences were significant: OS: 83.8% vs 82.0% FFS: 81.3% vs 77.3%   The study investigators noted that "the minimal benefit in failure-free survival and overall survival in stage I-II endometrial cancer achieved with chemoradiotherapy does not seem to justify the increased frequency of adverse events, impaired quality of life, and longer treatment duration of combined treatment for these patients." Patients with serous histology also appeared to benefit more from the addition of chemotherapy in the post-hoc analysis. After adjusting for stratification factors, OS at 5 years was 71.4% versus 52.8% in the chemoradiotherapy and radiotherapy groups, respectively (HR 0.48, 95% CI 0.24-0.96, P=0.037). And FFS at 5 years was 59.7% versus 47.9% (HR 0.42, 95% CI 0.22-0.80, P=0.008). For the question of whether chemotherapy might be sufficient alone in the adjuvant setting, Randall pointed to two NRG/GOG trials.   In stage I-II disease, Randall noted that in NRG/GOG 249 patients treated with chemotherapy plus vaginal cuff brachytherapy had no improvement in overall or relapse-free survival compared with those treated with pelvic radiotherapy alone. "However, the incidence of nodal failure was significantly higher in the absence of pelvic radiation therapy, and acute toxicity was greater in the vaginal cuff brachytherapy group," he wrote. Most recently, the phase III GOG 258 trial demonstrated similar outcomes between chemoradiotherapy and chemotherapy alone as adjuvant treatment for women with stage III-IVA endometrial cancer. At 5 years, 59% of women in the chemotherapy arm were estimated to be alive and relapse-free compared with 58% in the chemotherapy-alone arm. But Randall noted that while the combined therapy did not improve recurrence-free survival or OS, "nodal and vaginal failures were significantly lower when radiotherapy was given." Finally, he asked whether the chemoradiotherapy approach taken in both PORTEC-3 and GOG 258 was indeed the best option. "When NRG/GOG 258 was designed, there was vigorous debate about the combined modality group, with various investigators favoring a sandwich regimen typically involving three cycles of chemotherapy, followed by involved-field radiotherapy, and then additional chemotherapy," he wrote, adding that "multiple studies (retrospective and prospective) have demonstrated the safety and efficacy of the so-called sandwich approach." From 2006 to 2013, the PORTEC-3 trial randomized 660 patients 1:1 to either radiotherapy alone or chemoradiotherapy. Radiotherapy consisted of 48.6 Gy in 1.8 Gy fractions given 5 days per week, while chemoradiotherapy consisted of two cycles of 50 mg/m2 cisplatin given intravenously during radiotherapy, and then four cycles of intravenous carboplatin AUC5 plus paclitaxel 175 mg/m2. Adverse events (AEs) of grade ≥2 were significantly more frequent in the combined adjuvant therapy group, occurring in 38% of women versus 23% in the radiation-alone group (P=0.002), with 5-year neuropathy rates occurring in 6% versus 0%, respectively. Grade 3 AEs were similar between the chemoradiotherapy and radiation-alone groups (8% vs 5%, P=0.24), with hypertension being the most common event (2% in each group). Only one grade 4 AE was reported (in the chemoradiotherapy arm), and there were no treatment-related deaths.   de Boer disclosed no relevant relationships with industry. Co-authors disclosed support from Cancer Research U.K., the Canadian Cancer Trials Group, the Dutch Cancer Society, Health Holland, and the UMCG Cancer fund, as well as relevant relationships with SME Vicinivax, Aduro, TRON, and Merck. Randall disclosed a relevant relationship with Isoray Medical. Primary Source The Lancet Oncology Source Reference: de Boer SM, et al "Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): Patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial" Lancet Oncol 2019; DOI: 10.1016/S1470-2045(19)30395-X. Secondary Source The Lancet Oncology Source Reference: Randall M "Management of high-risk endometrial cancer: Are we there yet?" Lancet Oncol 2019; DOI: 10.1016/S1470-2045(19)30416-4.

Dermatologists can limit skin, hair, nail side effects from cancer therapy

By: Annual-Meeting | August 15, 2019 | 183 view(s)

NEW YORK — While new drugs for cancer are helping patients fight the disease, they also produce side effects that can affect the hair, skin and nails and can significantly affect quality of life and, potentially, the ability to continue treatment, according to a press release issued here at the American Academy of Dermatology Summer Meeting. “Approximately half of patients who undergo immunotherapy and receive targeted cancer medications experience a skin-related reaction to the medication,” Anisha Patel, MD, FAAD, an associate professor of dermatology and internal medicine at the University of Texas MD Anderson Cancer Center in Houston, said in the release. As many as 60% of patients experience hair, skin and nail reactions when combinations of targeted cancer therapies are used, according to Patel. Patel urges patients to seek treatment from a board-certified dermatologist prior to beginning any cancer therapies. Dermatologists can help patients with preventative strategies to reduce discomfort, such as limiting ultraviolet exposure, reducing friction and trauma to the hands and feet and avoiding manipulation of the nail cuticles, according to the release. Simple adjustments before treatment can greatly improve a patient’s comfort throughout therapy, according to Patel. Many cancer therapies make the skin extremely sensitive to UV light, so knowing up front if the medication requires strict sun protection will help prevent rashes and delays in care, she added. Potential side effects with these therapies include skin rashes, itchiness, changes in hair texture, inflammation around the nails and blisters in the mouth, Patel continued. “Dermatologists are an important part of an oncology patient’s treatment team,” Patel said in the release. “They can help reduce pain or discomfort associated with cancer therapy and limit visible side effects, increasing the patient’s ability to continue treatment, as well as the opportunity for a positive outcome.”   Disclosures: Patel reports no relevant financial disclosures.

Niraparib induces responses in late-line, BRCA-negative ovarian cancer

By: Annual-Meeting | August 15, 2019 | 169 view(s)

Niraparib demonstrated clinically relevant activity among women with heavily pretreated ovarian cancer, particularly those with homologous recombination deficiency-positive, platinum-sensitive disease, according to findings from the phase 2 QUADRA study published in The Lancet Oncology. The results, which also showed no new safety signals, support extending the use of poly(ADP-ribose) polymerase (PARP) inhibitors to a wider population of women with late-line ovarian cancer, including those without BRCAmutations, according to the researchers. “This is another piece of the puzzle that helps our patients live longer,” Kathleen Moore, MD, associate director of clinical research at Stephenson Cancer Center at University of Oklahoma College of Medicine, said in a press release. “There haven’t been a lot of studies done on patients without BRCA mutations who have received four, five, six or more lines of chemotherapy. That’s who this trial sought to study.” As many as 25% of women without a BRCA mutation can develop homologous recombination deficiency (HRD), which means they can derive benefits from PARP inhibitors such as niraparib (Zejula, Tesaro). In the multicenter, open-label, single-arm, phase 2 study, Moore and colleagues enrolled 463 women aged 18 years and older (median age, 65 years; range, 29-91) with metastatic, relapsed, high-grade serous (grade 2 or 3) epithelial ovarian, fallopian tube or primary peritoneal cancer who had undergone at least three prior chemotherapy regimens. Patients had ECOG performance status of 0 or 1 and adequate organ function and had received a median four (interquartile range [IQR], 3-5) previous lines of treatment. The study was conducted at 56 sites in the United States and Canada. Women received 300 mg oral niraparib once daily starting on day 1 and continuously through each 28-day cycle until disease progression, unacceptable toxicity or withdrawal of consent. The prevalence of confirmed overall response among women with HRD-positive tumors — including those with and without BRCA mutations — who showed sensitivity to their last platinum-based therapy served as the study’s primary objective. Efficacy analyses also were conducted among all dosed patients with evaluable disease at baseline. Median follow-up for OS was 12.2 months (IQR, 3.7-22.1). Among all women who initiated treatment, 151 (33%) had platinum-resistant disease and 161 (35%) had platinum-refractory disease. Results showed 13 of 47 women with platinum-sensitive, HRD-positive tumors naive to PARP inhibitors demonstrated overall response (27.65%; 95% CI, 15.6-42.6). These women had median PFS of 5.5 months (95% CI, 3.5-8.2) and median duration of response of 9.2 months (95% CI, 5.9 to not estimable), and 68% (95% CI, 53-81) achieved disease control.

Soricimed Announces Investigator Initiated Phase 1b Clinical trial of its Lead Drug Candidate in Late-Stage Pancreatic Cancer

By: Annual-Meeting | August 15, 2019 | 231 view(s)

TORONTO, CANADA / ACCESSWIRE / AUGUST 6, 2019 / Soricimed Biopharma Inc. ("Soricimed"), a clinical-stage pharmaceutical company developing first-in-class, targeted cancer therapeutics, announced today that The University of Texas MD Anderson Cancer Center (MDACC) has activated an Investigator Initiated Clinical trial of Soricimed’s lead drug candidate, SOR-C13 in late stage pancreatic cancer. This trial was initiated by Siqing Fu, MD PhD, a member of the Department of Investigational Cancer Therapeutics at MDACC, one of the world’s most respected cancer research centers, based on the results of Soricimed’s multi-center Phase 1 clinical trial in patients with late-stage solid tumor cancer. The Phase 1 trial concluded that SOR-C13 was safe and well tolerated, with preliminary indication of anticancer activity, including tumor regression in two late stage pancreatic cancer patients. The objectives of this Phase 1b investigator-initiated trial are to refine dosing and further explore safety and efficacy of SOR-C13 in late-stage solid tumor cancer. “We are pleased to be conducting this trial with the support of Soricimed Biopharma Inc.”, stated Principal investigator, Siqing Fu, MD PhD, Professor at the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center. “Pancreatic cancer is a difficult to treat cancer. We were intrigued by the positive efficacy signals we observed in the pancreatic cancer patients treated with SOR-C13 at our site in Soricimed’s Phase 1 clinical trial. With this next trial, among other critical data, we look to expand our data in pancreatic cancer patients and confirm the efficacy results seen earlier.” “We’re pleased to extend our clinical relationship with MD Anderson in advancing our understanding of the potential of SOC-C13 to treat pancreatic cancer and other important cancers,” said Dominique Dugourd, Vice President Research and Development, Soricimed Biopharma Inc. “It is our hope that our commitment to research will eventually yield a novel therapy for patients with significant unmet treatment needs.” The single arm, open label study of SOR-C13 ( identifier NCT03784677), will enroll approximately 36 patients with advanced solid tumor cancers with an emphasis on enrolling those patients with late-stage pancreatic cancer. The study’s primary objective is to define a maximum tolerated dose (MTD) for SOR-C13 and further define its safety profile. Secondary objectives include the evaluation of clinical response to SOR-C13 and to determine predictive biomarkers in patients who have achieved objective responses. The initial dose escalation cohorts will be followed by an expansion cohort to monitor clinical response. To learn more about the clinical trial visit: About SOR-C13: SOR-C13 is a selective inhibitor of TRPV6, a calcium oncochannel over-expressed by solid tumour cancers. SOR-C13 binds with high affinity and selectivity and disrupts the function of TRPV6. TRPV6 plays a central role in a biochemical cascade that results in the upregulation of an array of pro-cancerous genes. TRPV6 is considered to be an important target for novel anticancer therapy. SOR-C13 is the first highly specific TRPV6 inhibitor to be identified and taken into clinical development. About Soricimed Biopharma: Soricimed Biopharma Inc., is a private, clinical-stage company focused on developing first-in-class targeted cancer therapies. Our lead drug candidate, SOR-C13, completed a multi-center Phase 1 trial in late-stage solid tumor cancer. SOR-C13 was shown to be safe and well tolerated with over half of the patients treated having stable disease after 2 treatment cycles. Two patients with stage IV pancreatic cancer showed tumor size reduction with one patient achieving a 30% reduction in the size of the primary pancreatic tumor. The U.S. FDA granted orphan-drug designation to SOR-C13 for the treatment of ovarian cancer and for the treatment of pancreatic cancer. Privately held, Soricimed is funded through private investors and various programs from the Governments of Canada and New Brunswick. For more information please visit, For More Information: Julie A. FotheringhamPartner, HAGEMAN CommunicationJulie.fotheringham@hageman.ca416.951.7988 SOURCE: Soricimed Biopharma Inc. View source version on