Yervoy/Nivolumab May Need Stronger Survival Data To Be First Choice In Melanoma

Bristol’s combo demonstrates similar response rate as PD-1 alone, but with much better survival rates in a small melanoma study presented at ASCO. Due to toxicities, including one death, some say combination would need to shore up survival benefit to become first choice in frontline therapy.

CHICAGO – The combination of Bristol-Myers Squibb Co.’s CTLA-4 inhibitor Yervoy (ipilimumab) and PD-1 inhibitor nivolumab will need to show very high survival rates in large studies to secure a role in frontline treatment of melanoma, in light of the significant toxicities for the combo and the strong performance of PD-1 monotherapy, said specialists at the American Society of Clinical Oncology annual meeting.

In follow-up data for the combo in 53 Stage 3/4 melanoma patients taking part in a broader Phase I trial,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By 

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

More from R&D

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By 

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By 

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.