Bristol-Myers' nivolumab impresses once again--this time in crucial lung cancer study

Bristol-Myers Squibb's closely watched checkpoint inhibitor nivolumab managed to wow analysts this morning with impressive survival results in a Phase II study of patients with advanced squamous cell non-small cell lung cancer. Of all the patients in the drug arm, 41% were alive at the one-year mark, while investigators tracked an overall response rate of 15%.

Investors loved it. Bristol-Myers' shares ($BMY) soared more than 8% this morning.

Analysts quickly zeroed in on that 41% survival figure for nivolumab (approved as Opdivo). Investigators for the company noted that historically the percentage of these patients still alive at one year hovered between 5% and 18%. ISI's Mark Schoenebaum excitedly noted in an email that company bulls had been looking for a 30% survival rate at the one-year mark, while he thought anything over 35% "would be excellent data." And he went on to note that "landmark OS (overall survival) probably more impt than median given likely late separation of OS curves, in my opinion."

You can also count Leerink's Seamus Fernandez among Bristol-Myers' fan club today. "Our conversation with BMY this morning also highlights median overall survival (OS) of 8.2 mos, which BMY believes could be as much as 2x what would normally be seen in this highly refractory pt population," Fernandez noted. "Furthermore, The fact that duration of response had not been reached at 12 mos adds to our excitement for positive outcomes in both of BMY's 2nd line survival studies."

The cheering section is also likely more than a little relieved. Bristol-Myers had stirred some significant unease earlier in the year after it failed to fully explain why it was delaying a planned regulatory filing for nivo in lung cancer. As Bernstein's Tim Anderson explained in his review, that may have been the result of BMS's need to send along 12-month rather than 6-month results for the single-arm study. The company's historical survival trend number is based on older Medicare patients, which may have skewed it in nivo's favor. And the FDA may have trouble approving a drug based on a single-arm study. Still, he adds, the results are reassuring, easing fears that the numbers may have turned sour.

Bristol-Myers has been investing heavily in lung cancer studies, looking to beat rivals like Merck ($MRK) to the market with a PD-1 drug that can extend the lives of patients. It recently filed for an approval in Europe and now appears well on its way to adding a major market niche to the maiden approvals handed out on skin cancer. Analysts consider lung consider a much larger market, which has driven a frenetic race to the regulatory finish line. Among the leaders in the checkpoint field are Roche ($RHHBY) and AstraZeneca ($AZN).

These PD-1 checkpoint inhibitors are designed to dismantle a stealth mechanism cancer cells rely on to escape detection by the immune system. There's been growing evidence that these drugs will be the first to allow the immune system to marshal its forces to fight cancer, creating a natural combination approach with existing and experimental drugs that can provide a 1-2 punch for even greater efficacy. And a host of follow-up drug candidates are entering the clinic as a broad range of biopharma companies look to stake out a section of what promises to be a megamarket opportunity valued in the tens of billions of dollars.

"The Phase II findings from CheckMate -063 are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies," said Emory University's Suresh Ramalingam.

- here's the release

Special Report: The top 15 late-stage blockbusters in the pipeline - Nivolumab, Bristol-Myers Squibb

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