Study stopped early as BMS' Opdivo bests Afinitor in kidney cancer

Bristol-Myers Squibb ($BMY) can brag about another success with immunotherapy Opdivo. A late-stage study in advanced kidney cancer will be stopped early, after a monitoring committee flagged improved survival results for Opdivo, compared with the Novartis ($NVS) treatment Afinitor.

Bristol-Myers Squibb oncology SVP Michael Giordano

The full data will be unveiled at an upcoming conference, Bristol-Myers said in a statement, but the company did emphasize that Opdivo is the first checkpoint inhibitor to prove itself in a kidney cancer trial. And the company said it's aiming to change the treatment landscape for renal cancer.

"Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival," said oncology SVP Michael Giordano in a statement.

The latest data comes from Bristol-Myers' ongoing CheckMate series of studies on Opdivo, which have already yielded approvals in melanoma and non-small cell lung cancer. The drug nabbed an OK in melanoma late last year, and scored early clearance for squamous NSCLC in February. In another CheckMate study, Opdivo helped non-squamous NSCLC patients live longer, setting the stage for an approval in that group, too.

Bristol-Myers is racing Opdivo against Merck & Co.'s ($MRK) Keytruda, which hit the market last year as well. It's under review at the FDA for a lung cancer approval, and Merck is developing it for a variety of other cancers. Meanwhile, Roche ($RHHBY) is raring to go with its own checkpoint inhibitor--targeting PD-L1 rather than PD-1 as Opdivo and Keytruda do. The Swiss drugmaker unveiled a successful bladder cancer trial last week. AstraZeneca ($AZN) is racing to market with its own immunotherapy as well.

It's Opdivo, however, that analysts have pegged as the likely leader in the PD-1/PD-L1 field. The Bristol-Myers drug was recently tagged as an $8.2 billion drug by 2020, which would place it in third place for sales worldwide. Other analysts see the checkpoint inhibitor group bagging $33 billion in sales eventually, with Bristol-Myers grabbing 37% of that market.

- see the release from Bristol-Myers

Special Reports: Biopharma posts a chart-topping 41 new drug approvals in 2014 | Top 10 best-selling cancer drugs of 2013

Suggested Articles

The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.

Ultragenyx is back with another FDA nod, this time for Crysvita to treat X-linked hypophosphatemia in patients one year and older.

Roche got a two pieces of good Hemlibra news early this week—and what's good for Hemlibra must be good for Roche.