Merck’s immuno-oncology team has become expert at pressing an early advantage.
The Keytruda company, which recently trounced Bristol-Myers in their rivalry on lung cancer, has now filed an early and stunning application to market a combination of Keytruda and chemo for first-line lung cancer. And the move has the potential to carve out a shortcut that will allow them to cut ahead of a struggling AstraZeneca and a potent Roche.
Merck’s stock $MRK spiked close to 5% on the news of its latest advance in the field as analysts pondered the implications in a field with blockbuster potential. Checkpoints alone treat only a portion of all cancer patients, and a frontline combo could capture the lion’s share of the market.
The FDA accepted the supplemental application and agreed to give the application a speedy review, offering a decision by May 10. And given the agency’s go-go record on rushing ahead on promising I/O therapies, Merck may be on the verge of making an even earlier breakthrough with its first combo approach.
AstraZeneca earlier retooled its immuno-oncology effort for durvalumab, its all-important checkpoint program, as it lagged behind the frontrunners in the field. It’s now lining up for the fourth or possibly fifth new approval for a checkpoint, as it looks to enter a crowded market involving some of the most aggressive players in the industry. And after multiple setbacks over the past year, the UK giant can ill afford to continue getting beat in I/O if it ever expects to deliver on ambitious forecasts of revenue growth.
AstraZeneca’s stock dropped 1% on the news.
Merck’s play here is not without risk. Seamus Fernandez at Leerink noted:
MRK’s announcement of the acceptance of an sBLA filing for Keytruda (pembrolizumab) + chemotherapy in first-line (1L) non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 status comes as a significant surprise, potentially establishing Keytruda as the first IO agent to be used broadly in non-squamous NSCLC regardless of PDL1 status. FDA’s willingness to accept the filing based on such a small study (with no evidence of a survival benefit in the data presented at ESMO) suggests to us that the agency may have visibility into the likelihood of success on the PFS endpoint in the ongoing Phase 3 Keynote-189 trial. If this combo receives accelerated approval by its PDUFA date of 5/10/17, it likely would give MRK another leg-up in the 1L NSCLC race over AZN (OP) and BMY’s (OP) IO+IO combos and RHHBY’s (NR) IO+chemo combo. While we continue to believe that IO+IO combos will eventually produce more durable responses (particularly in patients with higher levels of PD-L1 expression), an early and broad accelerated approval for this IO+chemo combo could further establish Keytruda as the PD-1 of choice in the 1L setting – at least until other agents are approved in this setting.
Merck has mounted hundreds of studies around its Keytruda franchise, often partnering on potential combos as the team marries an immune system attack with complementary therapies.
Bristol-Myers has also been laboring long and hard with Opdivo. But it’s early lead in the field was badly damaged in 2016 as an overly ambitious attempt to grab proof of efficacy as a standalone lung cancer drug ended in disaster.
Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, has this to say:
“Keytruda in combination with chemotherapy has shown promise versus chemotherapy alone in the first-line treatment of non-squamous metastatic non-small cell lung cancer, regardless of PD-L1 levels. If approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced non-small cell lung cancer.”
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