Bristol shrugs off comparisons to MYSTIC
- Investors and analysts were less interested in Bristol-Myers Squibb’s actual second quarter earnings on Thursday as they were with the failure of competitor AstraZeneca’s lung cancer trial.
- The drugmaker’s second quarter call was dominated with questions from analysts about the impact of the MYSTIC trial results on the PD-1/L1 class, and more specifically, Bristol’s Opdivo (nivolumab).
- Shares of Bristol dropped sharply Thursday morning after news of AstraZeneca’s MYSTIC failure became widespread. Shares recovered slightly by the end of the day to close down 3.11% at $54.24.
While the miss of progression-free survival in MYSTIC shouldn't impact Opdivo, the failure has analysts and investors wondering if the Checkmate-227 trial is doomed to face a similar fate.
"It's very hard to walk away from MYSTIC feeling warm and fuzzy about '227," noted Goldman Sachs analyst Jami Rubin on the call.
AstraZeneca’s MYSTIC study tested its PD-L1 inhibitor Imfinzi (durvalumab) in combination with its CTLA4 inhibitor tremelimumab in patients with lung cancer. Checkmate-227, which is due to report data as early as the fourth quarter, is testing Bristol’s blockbuster PD-1 Opdivo with its own already-marketed CTLA4 inhibitor Yervoy (ipilimumab), also in non-small cell lung cancer.
Bristol-Myers CEO Giovanni Caforio and other execs faced an onslaught of questions about MYSTIC during the July 27 call with analysts, but tried to reassure investors that comparisons were not appropriate.
"There's much about MYSTIC that we don't know. All we've seen is the same press release that you saw this morning," emphasized Bristol’s Chief Scientific Officer Thomas Lynch, who noted that the CTLA4 mechanism has shown a proven survival advantage in other trials and tumor types.
Caforio continued to defend the company’s franchise, noting the differences between ‘227 and MYSTIC.
"With respect to the design of the study, first of all, size is really important. Second, we should remember that the studies include two different medicines, both in terms of the PD-1 and PD-L1 and in terms of the CTLA4. Dose and schedule are extremely important," he said.
But the defense of the program didn’t stop there, and analysts didn’t stop asking.
"They're different drugs. And dose and schedule may be important. We've spent a lot of time with Yervoy optimizing its dosing schedule across different tumor types. And we found that there are differences across that. The second is the PD-1 target is different. We're a PD-1 drug, that's a PD-L1 drug … So I think it's very difficult to read across the two studies,” Lynch added.
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