Merck's Keytruda snags 40th US indication, leaps ahead of GSK with broad endometrial cancer approval

18 Jun 2024
www.fiercepharma.com
Clinical ResultPhase 3Drug ApprovalImmunotherapyPriority Review
First-line endometrial cancer marks the 40th indication for Keytruda in the U.S.
The world’sendometrial cancercine is still adding new uses, Keytrudalatest FDA approval marks a first in the cancer immunotherapy class.
Merck & Co.’s Keytruda has received the FDA’s green light for use in combination with chemotherapy, followed cancer PD-1 inhibitor as a single agent, in patients with primary advanced or recurrent endometrial cancer, the company said Monday.
Merck & Co.l mKeytruda 40th U.S. indicatFDA for Keytruda, which generated $25 billion in sales globally last year.PD-1primary advanced or recurrent endometrial cancerprimary advanced or recurrent endometrial cancer
The new nod also allows Keytruda to leapfrog GSKKeytruda PD-1 inhibitor Jemperli, which in July 2023 got the FDA’s blessing in first-line endometrial cancer. But Keytruda’s approval still claims a first because it covers tumors regardless of their mismatch repair status, which is a genomic biomarker. Jemperli’s nod, at least for now, is limited to a small subset of patients whose cancer is mismatch repair deficient (dMMR).
Keytruda won over the FDKeytrudaime with dataGSKom the phPD-13 NRG-GY018Jemperlior Keynote-868. In the study,FDAe Keytruda-chemo regimen cendometrial cancerease pKeytrudaon or death by 70% in dMMR patients and by 40% in ptumorss with mismatch repair proficient (pMMR), compared with chemo alone. The data are slightly different from when the results of the study were first publishedcanceryear.
KeytrudaMMR cohort, paFDAnts in the control arm lived a median of 6.5 months without disease progression, and the Keytrudaas not reached for Keytruda. As to the pMMR group, the median progression-free survival was 8.5 months and 11.1 months for the two arms, respectively.
At the interim analysis, data on whether Keytruda could extend patients’ lives remained immature with 12% deaths in the dMMR cohort and 17% iKeytrudaMR population, according to the drug’s updated label. Although the exact overall survival data remain unclear, the FDA approval likely indicates that there’s at least no sign of any potential harm to patients’ life expectancy.
While Keytruda is the first to reach a brKeytrudat-line endometrial cancer population, Jemperli’s expansion beyond the dMMR subgroup may not be far away.FDA
After Keytruda follow-up of part 1 of the phase 3 RUBY tendometrial canceration to expaJemperlirli’s nod to include pMMR patients has been accepted by the FDA under priority review. The target decision date is August 23 this year.
In the RUBY trial, Jemperli and chemo significantly reduced thGSKisk of death by 31% in enJemperlil cancer patients regardless of their tumor’s mismatch reFDAr status. As such, Jemperli became the first PD-1/L1 inhibitor to claim a statistically significant overall survival win in first-line endometrial cancer in an overall population.
In the pMMR subgrouJemperliemperli-chemo combo showed a “clinically meaningful trend” inendometrial cancer of death by 21% versus chemo tumor, according to data released in MarcJemperliPD-1/L1 inhibitorPD-1/L1endometrial cancer
News of Keytruda’s latest Jemperli came on the same day of an AstraZeneca announcement that its PD-L1 inhibitor Imfinzi has also secured an FDA approval in first-line dMMR endometrial cancer as part of a combination with chemo. An AZ spokesperson said the company will continue to evaluate overall survival data to potentially help Imfinzi reach even more patients.
Besides,KeytrudaK and AZ are assessing adding a PARP inhibitorAstraZenecaespective immunotherapiPD-L1th positiveImfinzigs so far. But neitheFDAompany has made any regudMMR endometrial cancereir PARP-containing cocktails.Imfinzi
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