Ramucirumab Study: Good Safety Profile & Patients With Aggressive Tumors Respond Certainly To RAM

Ramucirumab Study: Good Safety Profile & Patients With Aggressive Tumors Respond Certainly To RAM

Annual-Meeting

7 months
28 Views
Share
Want to watch this again later?
Sign in to add this video to a playlist. Login
0 0
Category:
Description:
Josep Llovet, MD Of Mount Sinai School of Medicine Discusses Ramucirumab Study: Good Safety Profile & Patients With Aggressive Tumors Respond Certainly To RAM.




BACKROUND:
Len, an inhibitor of VEGF receptors 1-3, FGF receptors 1-4, PDGF receptor ?, RET, and KIT, is approved for first-line treatment of unresectable HCC (uHCC) based on the open-label phase 3 REFLECT study in which len showed noninferior overall survival (OS) and significantly improved objective response rate (ORR), progression-free survival (PFS), and time-to-progression (TTP) vs sorafenib. In the phase 2 KEYNOTE-224 study of pembro (a PD-1 inhibitor) as second-line treatment of advanced HCC, pembro showed meaningful clinical efficacy in pts previously treated with sorafenib, with median PFS 4.9 mo, median OS 12.9 mo, and a manageable safety profile. In results from the phase 1b KEYNOTE-524 trial, len+pembro was well-tolerated, with promising antitumor activity in pts with uHCC. LEAP-002 is a phase 3 study to evaluate the safety and efficacy of len+pembro vs len+placebo as first-line therapy for advanced HCC.




METHODS:
Eligible pts are ?18 y and have HCC confirmed by radiology, histology, or cytology; ECOG PS 0/1; BCLC stage C or stage B disease not amenable to locoregional therapy or curative treatment approach; CP class A liver score within 7 days before study; and ?1 measurable lesion by RECIST v1.1. Pts with past or ongoing HCV infection and those with controlled HBV are eligible. 750 pts will be randomized 1:1 to receive len 12 mg (body weight [BW] ?60 kg) or 8 mg (BW <60 kg) orally once daily plus pembro 200 mg or placebo IV Q3W. Pembro and len will be administered until disease progression or unacceptable toxicity, with a maximum 35 cycles for pembro. Stratification will be by geographic region (Asia vs Japan and Western regions); macroscopic portal vein invasion or extrahepatic spread or both (yes or no); alpha fetoprotein ?400 ng/mL vs >400 ng/mL; and ECOG PS 0/1. Primary end points are PFS per RECIST v1.1 by blinded independent central review (BICR) and OS. Secondary end points are ORR, duration of response, disease control rate, and TTP per RECIST v1.1 by BICR, efficacy per modified RECIST, pharmacokinetics, and safety. Imaging assessments will be performed Q9W on study. AEs will be graded per CTCAE v4.0 and monitored up to 90 days after last dose. Clinical trial information: NCT03713593
Up Next Autoplay
Phase 3 TAGS Study Evaluating LONSURF
Phase 3 TAGS Study Evaluating LONSURF
Category: Gastrointestinal Cancer
21 Views
Cancer-News 3 weeks
Drug Resistance Found as Instestinal Tumor: How This Affects Clinicians
Drug Resistance Found as Instestinal Tumor: How This Affects Clinicians
Category: Gastrointestinal Cancer
15 Views
Massachusetts General Hospital 3 months
Cause of Drug Resistance Found in a Form of Intestinal Tumor
Cause of Drug Resistance Found in a Form of Intestinal Tumor
Category: Gastrointestinal Cancer
27 Views
Massachusetts General Hospital 3 months
Intestinal Tumor Commonly Asked Questions
Intestinal Tumor Commonly Asked Questions
Category: Gastrointestinal Cancer
24 Views
Massachusetts General Hospital 3 months
Drug Resistance Found As Intestinal Tumor
Drug Resistance Found As Intestinal Tumor
Category: Gastrointestinal Cancer
25 Views
Massachusetts General Hospital 3 months
KEYNOTE-062: Pembrolizumab in HER2-, PD-L1  Positive Advanced Gastric Cancer
KEYNOTE-062: Pembrolizumab in HER2-, PD-L1 Positive Advanced Gastric Cancer
Category: Gastrointestinal Cancer
182 Views
obr 7 months
When Do You Prescribe Bland Vs Chemo Or Radio Embolization: Chemo Embolization Has Not Caught On In Our Institution Because The Side Effects & Extra Months Of Durability Are Not Of Value
When Do You Prescribe Bland Vs Chemo Or Radio Embolization: Chemo Embolization Has Not Caught On In Our Institution Because The Side Effects & Extra Months Of Durability Are Not Of Value
Category: Gastrointestinal Cancer
219 Views
Annual-Meeting 7 months
Inducing Embolization Syndrome When Performing infarction: Not Uncommon To Take 4-8 Weeks To Get Over The Treatment Of Embolotherapy
Inducing Embolization Syndrome When Performing infarction: Not Uncommon To Take 4-8 Weeks To Get Over The Treatment Of Embolotherapy
Category: Gastrointestinal Cancer
27 Views
Annual-Meeting 7 months
Evaluating mTOR Inhibitor Everolimus With Embolotherapy: Objective Response Rate Of 57 We Did Not Stop Everolimus During Embolotherapy, We Continued It
Evaluating mTOR Inhibitor Everolimus With Embolotherapy: Objective Response Rate Of 57 We Did Not Stop Everolimus During Embolotherapy, We Continued It
Category: Gastrointestinal Cancer
127 Views
Annual-Meeting 7 months
Caring For Every Patient And Learning From Every Patient
Caring For Every Patient And Learning From Every Patient
Category: Gastrointestinal Cancer
160 Views
Annual-Meeting 7 months