Merck, hedging its bets against Bristol-Myers Squibb and AstraZeneca, strikes up Keytruda-CTLA4 combo trial

It remains to be seen whether chemo or CTLA4 will emerge as the preferred partner for PD-1/PD-L1 meds in first-line lung cancer. So Merck is trialing both.

The New Jersey drugmaker, which recently won FDA approval for a pairing of Keytruda and chemo, has started up a phase 1 trial testing its red-hot immuno-oncology drug alongside CTLA4 candidate MK-1308. In doing so, it follows rivals AstraZeneca and Bristol-Myers Squibb, which are much further along with their tandems.

RELATED: With ASCO data tallied, Bristol-Myers loses ground to Merck in I-O field

In light of the competition, Bernstein analyst Tim Anderson said Merck needs to “go big or go home” with its duo. “Unless Merck believes it has a differentiated product, it is difficult to justify development of this new molecule given the substantial lead-time advantage that its two competitors have in this area,” he wrote in a Thursday note to clients.

What would make the study “easier to justify,” in Anderson’s opinion? Simultaneously launching another combination trialthis one marrying Keytruda and Bristol’s CTLA4 med, Yervoy—the only one currently on the market. This way, as he sees it, if Bristol or AZ succeed with their trials, “Keytruda would remain relevant in the nearer-term” in the setting.

“As long as Merck generates clinical data like this, physicians would likely feel comfortable mixing-and-matching” Merck and BMS’ products, he hypothesized. “Then, Merck has more time to eventually come in with a CTLA4 of its own.”

Of course, it’s entirely possible that the CTLA4 approach will fall short of what Merck’s chemo combo did in trialsa prospect that’s daunting especially for Bristol, which has pinned its hopes on a front-line combo after flopping a shot at a monotherapy approval.

But in Anderson’s view, it’s “wise” for companies to pursue a “multiple-shots-on-goal approach, given the unanswerable question about which products/regimens/combinations may ultimately become the standard of care.”

RELATED: Another Opdivo setback for Bristol, this time on the combo front, widens Merck's immuno-oncology lead

Investors will likely have more clarity on the situation later on this year, when AstraZeneca should have its CTLA4 combo data in hand. Bristol likely won’t have its own results until 2018, thanks to a January decision to pass up an accelerated filing for its Opdivo-Yervoy set.