$20B-plus? Merck keeps racking up PhIII successes, scoring on triple negative breast cancer challenge as analysts drive up peak sales estimates
Just days after Bristol-Myers Squibb managed to surprise the analyst brigade with a Phase III flop for its PD-1 checkpoint Opdivo combined with chemo in lung cancer, Merck’s dominant team is back with another solid hit for a particularly tough-to-treat subgroup of breast cancer patients.
Merck’s Phase III KEYNOTE-522 trial connected on one of two primary endpoints, with their Keytruda/chemo combo eliminating all signs of triple-negative breast cancer — what’s called a pathological complete response — at a significantly higher rate than chemo alone, regardless of PD-L1 levels in the neo-adjuvant setting.
That’s another first for Merck, which has been steadily racking up new Phase III successes for the marquee PD-1. Investigators are continuing the trial as they wait to see how Keytruda/chemo did on event-free survival.
As usual, we’ll have to wait for a scientific conference to see the hard numbers. But it’s important to note that Merck’s string of successes with Keytruda is also a psychological victory that can’t be underestimated. When Bristol-Myers released its latest batch of data on Opdivo, the company also claimed a success on Part 1a of the Checkmate -227 trial, which met the co-primary endpoint of OS, “demonstrating a statistically significant benefit for Opdivo plus low-dose Yervoy (ipilimumab) versus chemotherapy in patients whose tumors express PD-L1 ≥1%.”
Analysts weren’t having it, though, skeptical that the drug would beat Keytruda after seeing the Keynote-189 data. At this stage of the PD-1 battle, Bristol-Myers is assumed to come in behind Merck.
The string of successes has analysts competing in peak sales forecasts for Keytruda. Mizuho’s Mara Goldstein recently noted:
News of the failure of BMY’s Checkmate-227 Part 2, OPDIVO + chemotherapy in frontline NSCLC to demonstrate an OS benefit vs. chemotherapy alone, further solidifies KEYTRUDA’s dominance in this multi-billion dollar market opportunity, in our view, and is supportive of our investment thesis. We estimate that KEYTRUDA sales will surpass $20 billion by 2024, and that KEYTRUDA will remain the dominant checkpoint inhibitor in the market.
Goldstein added this morning that everything is still looking rosy for Merck as the company looks to add to its lead in triple negative breast cancer. Plus, the Europeans are helping with another positive opinion for Merck.
In addition to TNBC, MRK also announced a positive CHMP opinion for KEYTRUDA+INLYTA in 1L RCC based on pivotal Phase III KEYNOTE-426 data – improved OS, PFS, and ORR vs SUTENT. We think this lends support to our view that KEYTRUDA should pull farther ahead of competitors as the leading checkpoint inhibitor, and is supportive of our investment thesis.
Social image: Shutterstock