Approval of Pre- and Post-Operative Keytruda s ‘Big Step Forward’ for Lung Cancer

The use of immunotherapy continues to grow for patients with cancer.

The recent approval by the Food and Drug Administration (FDA) of Keytruda (pembrolizumab) for the perioperative (the time around surgery) treatment of patients with resectable (removable via surgery) stage 2, 3A or 3B non-small cell lung cancer (NSCLC), is part of a wave towards use of immunotherapy to improve the chances at cure for patients with lung cancer undergoing surgery, as one doctor told CURE®.

“This is being widely adopted throughout the country where lung cancer surgery is done commonly, because it’s clearly a big step- forward,” Dr. Gene G. Finley, assistant professor at Drexel University of College of Medicine and medical oncologist at AHN Cancer Institute, Allegheny Clinic Medical Oncology, said.

The approval was based on results of the phase 3, 786-patient KEYNOTE-671 trial evaluating presurgical Keytruda and chemotherapy followed by single-agent postsurgical Keytruda versus presurgical placebo plus chemotherapy and postsurgical placebo, which found that patient survival was improved with Keytruda.

Keytruda, as Finley explained, is part of a class “drugs that reinvigorate your immune system to fight the cancer,” as patients with lung cancer find themselves amidst game-changing movement towards the use immunotherapy in conjunction with surgery.

“Patients with stage 3 disease generally (were) not considered to be surgical candidates in the past, prior to the use of these neoadjuvant treatments or (immunotherapy) treatments that are given preoperatively,” Finley said.

Keytruda has joined a group of recently approved treatments, including Tecentriq (atezolizumab), which was approved in 2021 in the adjuvant setting for patients with stages 2 to 3A NSCLC and PD-L1-positive tumors after resection and platinum-based chemotherapy, and Opdivo (nivolumab) plus a platinum-doublet chemotherapy regimen as pre-surgical treatment for resectable NSCLC, which received approval from the FDA in 2022.

“What that means is, in practice for patients, say you have a potentially resectable lung cancer, but say it’s maybe stage 3 and maybe the surgeon is not very confident that they can get it all out or that they can do the surgery for a cure,” said Finley. “In that setting, in the old days, we would try to give (the patient) some chemo before the surgery to try to shrink the tumor down, but that really wasn’t that good of a strategy because the majority of patients would not respond to the chemotherapy. And so, it helped a little bit, but it wasn’t a big game changer.

“I would say that the use of (Opdivo) preoperatively and now the use of neoadjuvant therapy with chemo plus Keytruda has been shown to be effective in this preoperative space to shrink the tumor down (and) improve the rates of complete resection, rendering the patient curable and (meaning) more of the patients can be cured with surgery with this strategy. … In the old days, most lung cancers, 60% or so, were not considered to be able to undergo surgery. (Now,) some proportion of those (patients) with stage 3 lung cancer can be shifted over into this group that can be considered curable with preoperative treatment with chemo or with immunotherapy and chemo or with immunotherapy alone.”

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