Immuno-oncology, Results

#AACR18 round 1: Merck takes a direct swing at Bristol-Myers with adjuvant melanoma data for Keytruda

CHICAGO — Merck $MRK came out of its corner swinging Sunday morning, taking a few direct jabs at the defending champion in checkpoint inhibition as the pharma giant entered the latest I/O title fight with Bristol-Myers Squibb $BMY at the annual meeting of AACR in Chicago.

Roger Perlmutter, Merck

Researchers for Merck were in Chicago for the curtain opener in what promises to be a bruising brawl between the leaders in the PD-1 field over a market one analyst has said is worth $3 billion.

In KEYNOTE-054, Merck determined that 18 doses of Keytruda pushed post-surgery patients with stage 3 melanoma to a recurrence-free rate of 75.4% compared to 61% for a comparison group getting a placebo. A 43% drop in recurrence rate was something Merck touted as a major advance for patients.

Merck is looking to carve away market share from Bristol-Myers any way it can. And they’ll have their work cut out in Stage 3 melanoma. Bristol-Myers won an approval to use Yervoy in this group three years ago, and followed up with an OK for Opdivo last year, making them the go-to player for adjuvant therapy.

Merck, though, didn’t hesitate to make its case in their outline of the results Sunday morning. Yervoy, they note, is notoriously toxic for patients, who may well prefer an alternative. And Opdivo? They have an argument there as well.

“Nivolumab was more effective and had fewer side effects than ipilimumab, but it is given at a dose of 3 milligrams per kilogram every two weeks for up to a year, which is 26 doses in total,” noted Alexander Eggerment, director general of Gustave Roussy Cancer Campus Grand Paris, making Merck’s case. “Pembrolizumab may prove convenient to patients and hospitals because it requires fewer outpatient hospital visits and is given at a flat dose.”

Merck is hunting approvals in the US and Europe so they can take that pitch directly to physicians.

A spokesperson for Bristol-Myers, though, followed up with me to note that “the adjuvant melanoma dosing for nivolumab was updated with the Q4W approval and is now approved for flat dosing 240 mg every two weeks or 480 mg every four weeks.”

Bristol-Myers won an FDA approval after Checkmate-238 demonstrated that Opdivo was better than Yervoy in holding back melanoma for post-surgery stage 3 and 4 patients. In that study, the recurrence rate for Opdivo at a median follow-up of 18.5 months was 66.4% for Opdivo and 52.7% for Yervoy.

Whats at stake? According to Seamus Fernandez at Leerink, about $3 billion. Here’s his comment on the -238 results from last summer:

We estimate the adjuvant melanoma market will expand PD1 sales by approximately $3B globally. Although this likely will cannibalize sales of Yervoy in the setting (we estimate current adjuvant Yervoy sales at $300-400M), the expansion of the market should add approximately $1B to BMY’s net immuno-oncology (IO) sales despite assumed competition from MRK’s (MP) Keytruda (pembrolizumab; anti-PD-1).

It’s not just about money, though. Ever since Bristol-Myers rolled out in front of Merck, Roger Perlmutter’s team has been focused on claiming the lead. A key misstep on lung cancer at Bristol-Myers gave them an advantage they’ve been exploiting ever since — which we’ll also hear more about over the next two days.

This particular showdown has just begun.


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