Merck & Co. just scored a point in its immuno-oncology rivalry against Bristol-Myers Squibb. The PD-1 checkpoint inhibitor Keytruda hit its goals in a new trial in previously untreated non-small cell lung cancer patients, beating chemo at staving off cancer progression and extending patients’ lives.
Results from the Keynote-024 trial, like others in that development program, have been closely watched as Keytruda and Bristol-Myers’ Opdivo rack up data for a head-to-head competition in first-line lung cancer. At the recommendation of a trial oversight committee, Merck stopped the trial so that control patients could have the option of starting Keytruda treatment.
The new study tested Keytruda as a standalone treatment, rather than as part of a combination of meds. Patients in the trial had advanced NSCLC, and their tumors tested positive for PD-L1 levels of 50% or more.
The trial’s primary endpoint was progression-free survival, and its secondary goal was overall survival; Keytruda hit both. By what margin we don’t yet know; full results will be presented at an upcoming medical meeting, the company said.
Bernstein analyst Tim Anderson said the bar was higher for Keytruda in the Keynote-024 trial than in previous studies, because chemotherapy tends to work better in first-line patients than in those who’ve failed on previous treatment. If Keytruda hadn’t hit its goals, long-term sales forecasts would have been cut, Anderson said.
The trial results “should start to put Merck on a better commercial trajectory in lung cancer,” the analyst said in a Thursday note to investors. Keytruda and Opdivo are both approved as second-line treatments, but Opdivo has pulled ahead because it doesn’t require PD-L1 testing and Keytruda does.
“By contrast, in first-line disease, the playing field starts to level because both products will require PD-L1 testing,” Anderson said.
As Anderson points out, Bristol-Myers is running a similar trial with Opdivo, dubbed Checkmate-026, and it’s scheduled to read out this year, with results likely to be presented at the European Society of Medical Oncology meeting in October. The trials differ in that the PD-L1 threshold is 5% in the Opdivo trial, compared with 50% in Keytruda’s.
How the two trials stack up, numbers-wise, will be important to both drugs’ prospects in the first-line setting. Bernstein expects 2021 Keytruda sales of $3.8 billion in 2021 and more than $10 billion for Opdivo by then.
Meanwhile, Bristol-Myers rolled out data from a new analysis comparing Opdivo and its fellow BMS immunotherapy Yervoy against Opdivo alone in previously untreated lung cancer patients. Presented at the American Society of Clinical Oncology meeting earlier this month, the results showed that 57% of the combo patients responded, compared with the 28% Opdivo had achieved on its own in a separate trial, and the response rates were higher in patients with higher levels of PD-L1.
Merck R&D chief Roger Perlmutter said his company believes the Keynote-024 results “have the potential to change the therapeutic paradigm in first-line treatment of non-small-cell lung cancer.” We’ll know more about why when the full results go public.
- read the Merck release
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