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Narrow HCC CheckMate-459 Miss For Opdivo Points The Way For Combos, Roche Shows How

 
• By Alexandra Shimmings

Full data at ESMO show Opdivo managed to scrape a tolerability edge over standard-of-care sorafenib in liver cancer, but eyes were drawn to Roche’s early study of Tecentriq/Avastin as the way forward in this difficult-to-treat cancer.

liver
IO combination therapy may be best in liver cancer. • Source: Shutterstock

The full results of Bristol-Myers Squibb Co.’s CheckMate-459 study show Opdivo missed out on producing an overall survival benefit in the face of a better-than-usual performance by the current standard of care Nexavar in first-line treatment of hepatocellular carcinoma (HCC).

Despite a clear tolerability advantage for Bristol's PD-1 inhibitor in the trial, which its researchers say tip the balance in...

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Biogen’s Spinraza Follow-On May Offer Disease-Modifying Potential

 
• By Joseph Haas

Biogen hopes to move directly from Phase I to Phase III with salanersen, a higher-potency therapy that uses the same mechanism of action as Spinraza.

Nuvalent Believes Safety Profile Can Help Zidesamtinib Be ROS-1 Lung Cancer Leader

 
• By Andrew McConaghie

Zidesamtinib would be the fifth ROS-1 targeting therapy on the market, but Nuvalent believes its safety and efficacy profile will make it the best in class.

Nektar Bounces Back As Eczema Drug Rezpeg Heads For Phase III

 
• By Kevin Grogan

Lilly-rejected candidate impresses in Phase IIb atopic dermatitis trial.

Amgen’s MariTide Data Not The Hit Investors Sought

 
• By Joseph Haas

MariTide demonstrated solid 52-week weight loss in a Phase II update, but high rates of vomiting. Amgen is adjusting dosing in Phase III to seek a better tolerability profile.

More from R&D

Positive Fabry Data Should Smooth Way For Sangamo’s Partnering Efforts

 
• By Alaric DeArment

The biotech announced results from the pivotal trial of isaralgagene civoparvovec and plans to file for approval in 2026 as it looks for a commercialization partner.

Industry’s Vaccines Pipeline In A Changing Regulatory Landscape

 
• By Jessica Merrill

More than a dozen vaccines for infectious diseases are in Phase III development across the industry, as the US regulatory environment brings increased uncertainty.

Sanofi Links Up Again With Formation To Take Gusacitinib Down New Path

 
• By Kevin Grogan

Deal Snapshot: The Paris-headquartered company has licensed gusacitinib, which was in development for chronic hand eczema, but Sanofi will pursue a new indication for the dual JAK/SYK inhibitor.