Merck, Eisai further complicate kidney cancer race with Keytruda-Lenvima win

Merck & Co.’s Keytruda and its Eisai-partnered Lenvima are already separately approved in kidney cancer. Now, to further stir the pot, the pair showed the two meds can give the disease a one-two punch.

The combination of Keytruda and Lenvima beat Pfizer’s longtime standard therapy, Sutent, in newly diagnosed renal cell carcinoma, the two companies said Tuesday.

The win was a clear one. The duo was superior on all three major trial marks: It was better at shrinking tumors, staving off disease progression, and, most importantly, extending patients’ lives.

Detailed data remain under wraps, but the two drugmakers intend to share them with regulatory authorities to support potential approvals.

Both Keytruda and Lenvima have their separate combo approvals with other agents, too. For Lenvima, its use alongside Novartis’ Afinitor won an FDA green light in 2016 for kidney cancer patients after treatment with an angiogenesis inhibitor such as Roche's Avastin.

In a third arm of the new Keynote-581 trial, Merck and Eisai also pitted Lenvima-plus-Afiinitor against Sutent in first-line patients. That pairing did well on both inducing tumor response and slowing cancer progression, but there’s no word on whether it helped patients live longer. It’s not clear whether the Lenvima-Afinitor combo failed on the overall survival marker. The data simply may not be mature enough yet for that comparison. Merck hadn’t provided a clarification by press time.

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Those data will be key in a kidney cancer market that’s quickly getting more crowded. Keytruda, for its part, already boasts a nod for first-line treatment when used in tandem with Pfizer’s Inlyta, also after showing the pairing could top Sutent. At the point of its approval in April 2019, the median overall survival was not reached in either arm of the Keynote-426 trial, but data showed Keytruda-Inlyta cut the risk of death by 41% at 17 months of follow-up and 32% at 23 months.

Then, Bristol Myers Squibb joined the fray with Sutent-beating data for a combination of its PD-1 Opdivo and Exelixis’ tyrosine kinase inhibitor Cabometyx. And by the look of data presented at the European Society of Medical Oncology virtual annual meeting in September, that cocktail’s performance was very similar to what Keytruda and Inlyta delivered in their trial—to the extent that industry watchers found it difficult to call a clear winner.

RELATED: Merck, Eisai's Keytruda-Lenvima combo stonewalled in liver cancer after Roche's first-in-class green light

Besides the IO/TKI combo, Bristol Myers also has a dual I-O therapy that pairs Opdivo with its own CTLA-4 inhibitor Yervoy. An update from the phase 3 Checkmate-214 trial presented at this year’s ESMO showed that more than 50% of kidney cancer patients who got Opdivo and Yervoy as a first-line treatment were still alive at four years. At the 48-month follow-up, the death risk reduction was 31% for Opdivo-Yervoy over Sutent.

Now, the race will come down to the details of how Keytruda-Lenvima performed in the new Keynote-581 trial. Merck said it will present the data at an upcoming medical meeting.