Merck-Bristol showdown awaits as Keytruda scores in 1st line NSCLC

Merck ($MRK) has chalked up a key win in a new trial for its marketed checkpoint inhibitor Keytruda after it bested chemotherapy and improved overall survival in certain lung cancer patients—but the company now awaits data from its fierce rival Bristol-Myers Squibb’s ($BMY) own first-line trial in Q3.

So good were the apparent data from Merck--which have not yet been shared in detail by the company--that the Data Monitoring Committee has recommended that the trial be stopped, and that those patients receiving chemotherapy in the Keynote-024 study be offered the opportunity to use Merck’s drug.

The trial was assessing Keytruda in patients as a first-line treatment in non-small cell lung cancer (NSCLC) whose tumors expressed high levels of PD-L1 (tumor proportion score of 50% or more).

The drug met its primary endpoint after besting chemotherapy for both the primary endpoint of progression-free survival (PFS), and the secondary endpoint of overall survival (OS). The detailed data from the trial will be presented at an “upcoming medical meeting,” the Big Pharma said in a statement.

“We believe that the Keynote-024 results have the potential to change the therapeutic paradigm in first-line treatment of non-small-cell lung cancer,” said Dr. Roger Perlmutter, president, Merck Research Laboratories. “We look forward to sharing these data with the medical community and with regulatory authorities around the world.”

Merck was back in 2014 the first company to gain approval for the new class of cancer meds known as PD-1 checkpoint inhibitors, although hot on its heels has been Bristol-Myers Squibb and its Opdivo, also a PD-1 drug, that has taken the sales lead despite being second to market.

Keytruda’s current NSCLC license in the U.S. is for patients with an advanced form of the disease who test positive for PD-L1 and have failed on a platinum-containing chemotherapy.

It’s also for those patients with the EGFR or ALK gene who can use Keytruda after being treated with an EGFR or ALK inhibitor medicine, such as AstraZeneca’s ($AZN) Iressa or Pfizer’s ($PFE) Xalkori.

The latest trial from Merck is designed to try and bump it up the treatment pathway and therefore, should it gain a label extension, gain greater sales and compete harder against Opdivo.

But Opdivo is once again hot on its heels, and is expected to release its own data later this year on its first-line approach. Given its much larger market share and apparent better efficacy across licenses, should BMS also post positive data this could cancel out the positive vibes currently coming from Merck.

Opdivo’s NSCLC license was expanded by the FDA last year to treat advanced NSCLC whose disease progressed during or after platinum-based chemotherapy, and also targets PD-1/PD-L1 proteins. The FDA has previously approved the drug for squamous cell lung cancer as a second-line treatment.

Roche ($RHHBY)--which recently became the third to market a checkpoint inhibitor and the first direct PD-L1 player with its Tecentriq for bladder cancer--is also looking to get in on the NSCLC therapy area.

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