HCRN GU14-182 Questions: OS Is The Endpoint Needed To See To Impact Practice, Phase 3 Study Will Answer Future Questions

HCRN GU14-182 Questions: OS Is The Endpoint Needed To See To Impact Practice, Phase 3 Study Will Answer Future Questions

Annual-Meeting

6 months
48 Views
Share
Want to watch this again later?
Sign in to add this video to a playlist. Login
0 0
Category:
Description:
Matthew Galsky, MD, Director of Genitourinary Medical Oncology At The Tisch Cancer Institute at Mount Sinai Discusses HCRN GU14-182 Questions: OS Is The Endpoint Needed To See To Impact Practice, Phase 3 Study Will Answer Future Questions. BACKROUND: Platinum-based chemotherapy for 1st-line treatment of pts with metastatic urothelial cancer (mUC) is typically administered for a fixed duration followed by observation until recurrence. PD-1 blockade with pembro improves survival of pts with mUC progressing despite platinum-based chemotherapy. We explored the potential benefit of earlier use of PD-1 blockade using a "switch maintenance" approach. METHODS: Pts with mUC achieving at least stable disease after up to 8 cycles of 1st-line platinum-based chemotherapy were enrolled. Pts were randomized 1:1 to pembro 200 mg IV q3 weeks versus placebo for up to 24 months; pts progressing on placebo could cross over to pembro. Randomization was stratified based on pre-chemotherapy visceral metastases (Y/N) and response to 1st-line chemotherapy (CR/PR vs. SD). The primary objective was to determine the progression-free survival (PFS) as per irRECIST among pts treated with pembro versus placebo. RESULTS: Between 12/2015 and 11/2018, 107 pts were randomized to placebo (n=52) versus pembro (n=55). The baseline pt characteristics are shown in the Table. Pts randomized to placebo and pembro received a median of 6 and 8 cycles, respectively. Excluding patients with baseline CRs, the objective response rate was 12% (5/42) on placebo and 22% (10/46) on pembro. Grade 3-4 treatment emergent adverse events occurred in 48% of pts on placebo and 56% on pembro. At a median follow-up of 14.7 months, 41 pts have died and 26/52 pts randomized to placebo have crossed over to pembro. PFS was significantly longer in patients randomized to pembro vs. placebo (Maximum Efficiency Robust Test p=0.036; log-rank p = 0.038). The 18-month restricted mean progression-free survival time was 5.6 months with placebo and 8.2 months with pembro (p=0.023). CONCLUSIONS: Switch maintenance pembro may deepen responses achieved with 1st-line chemotherapy. Switch maintenance pembro prolongs PFS in pts with mUC completing 1st-line platinum-based chemotherapy. Clinical trial information: NCT02500121
Up Next Autoplay
Caris Life Sciences and Ambry Genetics Partner to Advance Cancer Care
Caris Life Sciences and Ambry Genetics Partner to Advance Cancer Care
Category: News
2 Views
Cancer-News 1 day
Long-Term Results from Phase 3 ALTA-1L Trial
Long-Term Results from Phase 3 ALTA-1L Trial
Category: Non-Small Cell Lung Cancer
26 Views
Cancer-News 2 days
Mount Sinai Receives $1 Million Grant for Prostate Cancer Research
Mount Sinai Receives $1 Million Grant for Prostate Cancer Research
Category: News
2 Views
Cancer-News 2 days
Treatment-Free Survival, With and Without Toxicity
Treatment-Free Survival, With and Without Toxicity
Category: Kidney Cancer
10 Views
kidneycancer 2 days
Phase 2 Study of Lenvatinib Plus Pembrolizumab for Disease Progression After PD-1/PD-L1
Phase 2 Study of Lenvatinib Plus Pembrolizumab for Disease Progression After PD-1/PD-L1
Category: Kidney Cancer
1 Views
kidneycancer 2 days
What's To Come in Modern Imaging Technology
What's To Come in Modern Imaging Technology
Category: Kidney Cancer
4 Views
kidneycancer 3 days
Moleculin Announces Additional Positive Interim Results from Phase 1/2 Clinical Studies of Annamycin in Acute Myeloid Leukemia
Moleculin Announces Additional Positive Interim Results from Phase 1/2 Clinical Studies of Annamycin in Acute Myeloid Leukemia
Category: Acute Myelogenous Leukemia
5 Views
Cancer-News 3 days
CytoDyn Reports Early Results from First Patient in its Phase 1b/2 CCR5+ Metastatic Triple-Negative Breast Cancer Trial
CytoDyn Reports Early Results from First Patient in its Phase 1b/2 CCR5+ Metastatic Triple-Negative Breast Cancer Trial
Category: Breast Cancer
6 Views
Cancer-News 3 days
Modern Imaging Technology
Modern Imaging Technology
Category: Kidney Cancer
10 Views
kidneycancer 3 days
ASH Releases New Clinical Practice Guidelines on Immune Thrombocytopenia
ASH Releases New Clinical Practice Guidelines on Immune Thrombocytopenia
Category: News
3 Views
Cancer-News 4 days