FDA approves Merck’s Keytruda as adjuvant cancer treatment regardless of tumor’s PD-L1 expression levels

USA — The U.S. Food and Drug Administration (FDA) has cleared Merck & Co.’s immunotherapy Keytruda to treat early cases of lung cancer despite mixed results in the main study supporting its application.

According to the company’s press release, the adverse reactions observed in KEYNOTE-091 were generally similar to those occurring in other patients with NSCLC receiving Keytruda as a single agent, with the exception of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%). Two fatal adverse reactions of myocarditis occurred.

The FDA approved Keytruda as an “adjuvant” treatment after chemotherapy and surgical removal of non-small cell lung tumors classified as Stage IB, II, or IIIA.

In a nutshell, adjuvant therapies are therapies, like chemotherapy or hormone therapy, delivered before or after the primary treatment, to help increase the treatment’s chance of success and decrease the risk of recurrence.

Notably, Keytruda was approved for widespread use regardless of the amount of a protein biomarker known as PD-L1 expressed on patients’ tumors.

Keytruda is a programmed death receptor-1 (PD-1)-blocking antibody. This approval marks the fifth indication for Keytruda in the treatment of non-small cell lung cancer (NSCLC).

Non–small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. Lung cancer is an especially important market because it is still one of the leading causes of cancer death.

Despite recent declines in lung cancer prevalence due to lower smoking rates, the American Cancer Society predicts that it will still account for the majority of cancer deaths in 2023.

According to studies, anywhere from one-third to more than half of non-small cell lung cancer patients who have their tumors surgically removed will have a recurrence.

Keytruda is now the only cancer immunotherapy with FDA approvals in both adjuvant and metastatic NSCLC, spanning the entire PD-L1 expression spectrum.

While Keytruda and Tecentriq are set to compete in adjuvant NSCLC, there is still debate over whether PD-1/L1 inhibitors should be used as neoadjuvant therapy before surgery rather than after surgery.

Merck’s drug joins Bristol Myers Squibb’s Opdivo and Roche’s Tecentriq as approved treatments for patients with early-stage lung cancer.

Bristol Myers Squibb’s Opdivo already entered the neoadjuvant setting, thanks to an FDA approval in March 2022.

However, each is used slightly differently. Opdivo is administered in conjunction with chemotherapy for nine weeks prior to surgery, whereas Roche and Merck’s drugs require much longer regimens following surgery.

Meanwhile, Merck has called it quits on a phase 3 trial of Keytruda in metastatic hormone-sensitive prostate cancer after an independent data monitoring committee ruled that the study likely wouldn’t be successful, the company said.

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