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UPDATED: Bristol-Myers flags early success for PhIII Opdivo study in kidney cancer

Bristol-Myers Squibb ($BMY) flagged an early success for its Phase III Opdivo (nivolumab) study for kidney cancer, saying that an independent monitoring group concluded that its closely watched checkpoint inhibitor has beat Afinitor (everolimus) in improving overall survival for advanced patients.

This is the first time that a checkpoint inhibitor has demonstrated success for renal cell carcinoma, says Bristol-Myers, which already scored a quick initial approval for the drug as it hurries to expand its portfolio for more cancers as Merck ($MRK), Roche ($RHHBY) and AstraZeneca ($AZN) all concentrate on their rival therapies in this group. Checkpoint inhibitors are essentially designed to dismantle cancer cells' evasive features, in this case by targeting PD-1, allowing the immune system to go after cancer. And they have demonstrated some remarkable successes in human studies.

"Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival," said Michael Giordano, senior vice president and head of development, oncology, for Bristol-Myers.

Bristol only heralded the top-line results from the study, noting that the data on Opdivo would be reported at an upcoming scientific conference. Bristol investigators recruited 821 patients for the Phase III trial, dubbed Checkmate-025.

Bristol-Myers also scored a European approval for nivolumab as a new treatment for squamous non-smalll cell lung cancer.

The news on the kidney cancer front somewhat overshadowed the celebration at Exelixis ($EXEL), which trumpeted the success of Cometriq (cabozantinib) over Afinitor for renal cell carcinoma. Bristol-Myers' shares were up 1% in mid-morning trading Monday. But the twin advances against Afinitor may well eventually slice into its revenue, according to Bernstein's Tim Anderson. 

Leerink's Michael Schmidt had counted himself as skeptical about Cometriq's chances, given the number of competing drugs in the clinic. He noted back in May that the Checkpoint-025 study could open the door to a rival approach, with other checkpoint inhibitors also focused on RCC. Roche's "atezo" in particular has been in a mid-stage RCC study. 

Bristol-Myers is pursuing a separate Phase III trial in RCC, combining Opdivo and Yervoy in a head-to-head against Sutent among frontline patients. That study isn't expected to be completed until 2018, but another early wrap is a distinct possibility.

- here's the release

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By John Carroll