Keytruda made history seven years ago as the first anti-PD-1 therapy approved in the US, winning an OK in metastatic melanoma. The drug has since become a megablockbuster, and on Friday earned a new approval in the field that got everything started.
The FDA rubber-stamped Keytruda’s use as an adjuvant, Merck announced, for multiple stages of melanoma in patients older than 12 following complete resection. Previously, Keytruda was approved in the adjuvant setting for adults with Stage III melanoma, but now can be used in adults and adolescents with Stage IIB, Stage IIC and Stage III melanoma as an adjuvant.
Merck’s push to get Keytruda in earlier lines of cancer comes as other checkpoint inhibitor players are attempting similar moves as well, potentially expanding the drugs’ market significantly. Last month, Merck won an OK in the adjuvant setting for kidney cancer, while Bristol Myers Squibb’s Opdivo earned a first-line approval for non-small cell lung cancer late last year.
Jason Luke, director of the University of Pittsburgh Medical Center’s cancer wing, noted in a prepared statement that the risk of recurrence in the earlier melanoma patients is nearly as high as those with later-stage disease.
‘Today’s approval … is an important advance that provides these patients with a new option that can help reduce the risk of their cancer returning,’ Luke said in the statement.
Over the years, Keytruda has staked itself out as a leader in the cancer immunotherapy arena, becoming one of the best-selling drugs in the world. But it all got started with melanoma, with Merck nabbing the first approval in the metastatic setting way back in September 2014.
Since then, Merck rapidly began expanding into other cancers, putting the drug into a vast amount of clinical trials and amassing huge chunks of data. In addition to the different cancers — NSCLC, head and neck squamous cell carcinoma, to name a few — Merck also began moving Keytruda into earlier lines of melanoma treatment.
Friday marked the latest step in that latter advance, and is Keytruda’s first approval in melanoma since February 2019 when it won the Stage III adjuvant OK in adults. The research has been underway for years, however, as Merck launched the relevant Phase III trial in mid-2018.
Keytruda’s new approval comes from a nearly 1,000-patient study where participants received the drug or placebo in a 1:1 randomized, double-blinded setting. Patients were excluded if they had previously received treatment beyond resection, and received the drug every three weeks for up to a year until their cancer came back or suffered from too much toxicity.
In the primary endpoint, Keytruda managed a statistically significant improvement in recurrence-free survival compared to placebo, reducing the risk of cancer returning or death by 35% (p-value of p=0.0132). Median RFS was not reached for either group, and after a median follow-up of 14.4 months, 11% of those on Keytruda had recurrence or died compared to 17% of patients on placebo.
Merck also noted in a release that ‘efficacy in pediatric patients (12 years and older) with stage IIB, IIC and III melanoma is supported by extrapolation of efficacy data from adults, given similar biology, pharmacology of drug effect, as well as similar exposure-response for efficacy and safety.’
It’s been a busy year for Keytruda, as Friday’s approval was the eighth time this year the FDA has waved through a new indication — the highest yearly total in the drug’s history. The newest OK comes, though, with researchers calling for reform and senior FDA officials openly discussing how to potentially change the accelerated approval pathway, with which Keytruda has heavily utilized.
https://endpts.com/keytruda-wins-ninth-fda-approval-of-2021-moving-into-adjuvant-and-pediatric-melanoma-settings/
