Merck Gains FDA Approval for Expanded Indication of Keytruda

Merck recently announced that FDA approved an expanded label for its anti-PD-1 therapy, Keytruda, as a monotherapy for patients with locally advanced cutaneous squamous cell carcinoma (cSCC).

The expanded label is indicated for patients with cSCC that is not curable by surgery or radiation. The approval was based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial.

In the trial, Keytruda demonstrated an objective response rate of 50 percent, including a complete response rate of 17 percent and a partial response of 33 percent in patients with locally advanced disease.

Out of 27 responding patients, 81 percent had a duration of response of six months or longer, while 37 percent had a duration of response of 12 months or longer.

“This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community. KEYTRUDA has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation,”  Vicki Goodman, MD, vice president of clinical research at Merck, said in the announcement.

“This expanded indication reinforces the role of KEYTRUDA in this cancer type, which is the second most common form of non-melanoma skin cancer,” Goodman continued.

Keytruda may elicit immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, solid organ transplant rejection, and allogeneic hematopoietic stem cell transplantation complications, a Merck spokesperson explained.

Early indication of immune-mediated adverse reactions is crucial to ensure safe use of Keytruda. The drug should be withheld or permanently discontinued based on severity of the adverse reaction. 

In May 2017, FDA granted accelerated approval to Keytruda for patients whose cancers have a specific genetic feature. This was the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. 

And in May 2021, Keytruda significantly helped patients with high-risk early-stage triple-negative breast cancer in a Phase 2 trial. But FDA recently requested more data from Merck on Keytruda for breast cancer. 

FDA officials stated a regulatory decision about Keytruda should be deferred until further data is available from its Phase 3 trial, KEYNOTE-522.