FDA Approval of Tecentriq Marks ‘Major Advance’ for Pretreated NSCLC

The FDA approval is based on ‘substantial’ disease-free survival results and may ‘drastically’ improve lung cancer survival.

The Food and Drug Administration’s (FDA) recent approval of Tecentriq (atezolizumab) in the adjuvant setting for patients with stage 2 to 3A non-small cell lung cancer (NSCLC) and PD-L1-positive tumors after resection and platinum-based chemotherapy is an important step in treating this population, according to an expert.

Dr. Sandip P. Patel, an associate professor of medical oncology at the University of California, San Diego, told CURE® that this approval “absolutely” meets a previously unmet need.

“This is a landmark approval and a milestone in improving the number of cancer patients who are cured after surgery,” he said.

The FDA approval was based on findings from the IMpower010 trial, in which researchers aimed to meet disease-free survival (period after successful treatment during which there are no signs and symptoms of cancer), which it did.

“The degree of disease-free survival benefit is substantial, particularly in the PD-L1 (greater than) 50% population, which represents about a third of patients with resected NSCLC,” Patel noted. “As NSCLC is the leading cancer killer in the U.S. and the world, improvements in curative intent therapy after surgery beyond adjuvant chemotherapy are needed, and adjuvant (Tecentriq) for one year after chemotherapy represents a major advance in lung cancer.”

The study included 1,005 patients with stage 2 or 3A NSCLC who underwent tumor resection and cisplatin-based adjuvant chemotherapy. Half of the patients received Tecentriq every three weeks for 16 cycles, and the other half received supportive care.

Notably, this was the first postoperative immunotherapy study to demonstrate improvement in disease-free survival for patients with PD-L1 greater than 1%, Patel said.

Median disease-free survival was 35.3 months in the supportive care group and was not yet reached with Tecentriq, meaning that more than half of patients were alive when this was assessed.

Patel added that prior to this approval, the alternative for patients with EGFR mutations was to receive three years of adjuvant Tagrisso (osimertinib) after surgery and four cycles of platinum-based chemotherapy. “The approval of (Tecentriq) could be relevant to almost two-thirds of patients with resected NSCLC with a PD-L1 score greater than 1%,” he said.

The most common side effects of Tecentriq that occurred at least 10% of patients included laboratory abnormalities, increased aspartate aminotransferase, blood creatinine, and alanine aminotransferase — all of which can point toward impaired liver function — high potassium levels, rash, cough, hypothyroidism, fever, fatigue/weakness, musculoskeletal pain, peripheral neuropathy, stiff joints and dry/itchy skin.

“While rare fatal side effects related to lung and cardiac autoimmune events were reported, the overall disease-free survival benefit in terms of mitigating cancer relapse favors treatment for patients lacking major autoimmune conditions,” Patel noted.

The three recommended doses for Tecentriq are 840 milligrams every two weeks, 1,200 milligrams every three weeks or 1,680 milligrams every four weeks. All three doses can be administered for one year after completing four cycles of cisplatin-based adjuvant chemotherapy for patients with resected stage 2 to 3A NSCLC and tumors that have a PD-L1 score greater than 1%.

“As these doses are all equally efficacious with similar toxicity profiles. I utilize 1,680 milligrams every four weeks for patient convenience,” Patel mentioned.

“After chemotherapy, a high proportion of patients, especially with lymph node-positive and higher-stage disease, would have relapses after their surgery even with chemotherapy. The ability for (Tecentriq) to reduce these relapses, especially in the PD-L1 (greater than) 50% population but likely in the PD-L1 1% (to) 49% population as well, can drastically improve lung cancer survival,” he concluded.

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