With Keytruda leading the way, Merck tallies 80-plus potential oncology approvals by 2028

Before the introduction of Keytruda, Merck & Co. wasn’t exactly a major oncology player. Now holding the world’s best-selling cancer drug, the New Jersey pharma looks to consolidate its leadership.

Merck has the potential to secure more than 80 oncology approvals from now to 2028, Jannie Oosthuizen, Merck’s president of global oncology, told investors this week during an event at the 2022 American Society of Clinical Oncology (ASCO) annual meeting.

That’s on top of the 46 existing approved U.S. indications from Merck’s oncology portfolio. More than 30 of those belong to Keytruda, the most of any oncology medicine, and Merck expects to double the number in the coming years, Oosthuizen said. With $17.2 billion in sales, Keytruda was the world’s top-selling cancer med in 2021.

Keytruda recently hit the milestone of 1 million commercial patients, and its expansion could accelerate to reach 2 million patients by the end of 2024, Oosthuizen added.

Moving into early-stage cancers represents a key avenue for Keytruda’s future growth. Since last year’s ASCO, Keytruda added three FDA nods for use around surgery in early cancers, bringing the total to six. The new additions include presurgery and postsurgery treatment of early triple-negative breast cancer, as a postsurgery adjuvant therapy for certain patients with kidney cancer and for completed resected stages 2B or 2C melanoma.

For potential near-term regulatory approvals, Merck recently touted a win from the KEYNOTE-091 trial for Keytruda in the all-important adjuvant non-small cell lung cancer (NSCLC) setting. And it expects a readout from the phase 3 KEYNOTE-671 trial, which tests Keytruda as both neoadjuvant and adjuvant treatment in stages 2 to 2B NSCLC.

All told, Merck is running 14 Keytruda phase 3 trials in early-stage disease between 2022 and 2025. Based on those numbers, Merck expects that by 2025, about 25% of total Keytruda revenue will come from early-phase settings, Oosthuizen said. During Merck’s fourth-quarter earnings call in February, Merck CEO Rob Davis pegged the early-stage proportion at 30%. A Merck spokesperson clarified to Fierce Pharma that Davis was specifically referring to Keytruda’s U.S. revenue.

But to really penetrate the early-stage setting, an FDA approval alone won’t be enough, Oosthuizen said.

“We’re working to ensure the full scale and capabilities of the organization—at the commercial organization—are meeting the needs of our customers by delivering highly relevant information to them when they need it and in the channel they prefer,” the executive said.

To that end, Merck is developing an under-the-skin version of Keytruda, which Oosthuizen said is important for the early-stage setting. And the company is utilizing digital marketing to support its commercial execution, he said.

In Merck’s broader oncology ambition, “new tumor types, earlier lines of therapy—including adjuvant and neoadjuvant—new mechanisms, combinations and formulations will all be important” as growth drivers, Oosthuizen said.

On the combination front, Merck is following some hot immunotherapy targets, including CTLA-4, LAG-3 and TIGIT, for potential pairing with Keytruda. Its AstraZeneca-partnered Lynparza, Eisai-shared Lenvima and Seagen-teamed Tukysa all have ongoing tests alongside Keytruda.

As for new mechanisms, Merck last year won FDA approval for Welireg to treat certain patients with rare von Hippel-Lindau disease-associated tumors. It’s the first HIF-2alpha inhibitor in the U.S. Merck is also evaluating the drug as a monotherapy in combo with Lenvima with or without Keytruda in various kidney disease settings.