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The data, according to an expert, show that treatment with Tecentriq could delay disease progression to an advanced stage, as well as the need for more aggressive therapy.
Treatment with Tecentriq (atezolizumab) following surgery was associated with a significant improvement in disease-free survival among patients with stage 2 to 3A non–small cell lung cancer (NSCLC), compared to the best supportive care.
Moreover, the data — which were presented during a news briefing prior to the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting — indicated that the benefit was particularly pronounced in patients who had a PD-L1–positive tumor.
“Though surgery can cure some patients with early-stage lung cancer, disease recurrence is still very common. Until this trial, the only treatment that was known to help reduce that risk for most patients was chemotherapy, or osimertinib [Tagrisso] for the small group of patients with tumors with an EGFR mutation,” said lead study author Dr. Heather Wakelee, a thoracic specialist and chief of the Division of Oncology at Stanford University Medical Center, in a news release. “These data show that personalized medicine with (Tecentriq) can reduce the chance of NSCLC returning after surgery for patients who have a tumor that expresses the biomarker PD-L1.”
Despite the progress that has been made for patients with early-stage disease who harbor EGFR sensitizing mutations, the standard of care remains platinum-based chemotherapy for most patients with resected NSCLC.
Patients had to have had completely resected stage 1B to 3A NSCLC to be enrolled onto the study. After 1,280 patients received between one and four cycles of the chemotherapy cisplatin plus pemetrexed, gemcitabine, docetaxel or vinorelbine, they were randomized to either Tecentriq every 21 days for 16 cycles (1,005 patients) or treatment with best supportive care (1,005 patients).
Measuring disease-free survival (the time after treatment without signs of cancer) in patients with stage 2 to 3A disease, as well as a PD-L1 expression of at least 1% on tumor cells, was the main goal of the study. Other goals included assessing overall survival and disease-free survival in patients with a high expression of PD-L1.
Among patients whose tumors expressed a PD-L1 expression of at least 1%, the data demonstrated that a median disease free survival (DFS) was not evaluable in 248 patients who received Tecentriq compared to a median DFS of 35.3 months in 228 patients treated with best supportive care. Two-year DFS rates were 74.6% in the Tecentriq group and 61% in the best supportive care group. Additionally, three-year DFS rates were 60% in those who received Tecentriq and 48.2% in the best supportive care group.
Treatment with Tecentriq in the other patients was associated with a median DFS of 42.3 months compared to 35.3 months in those who received best supportive care. Two-year DFS was 70.2% with Tecentriq and 61.6% with best supportive care. Additionally, the three-year DFS was 55.7% and 49.4%, respectively.
In terms of safety, 92.7% of 495 patients who received Tecentriq reported a side effect compared to 70.7% of 495 patients in the best supportive care group. Of note, 21.8% of the side effects in the Tecentriq group and 11.5% of side effects in the best supportive care group were considered serious or severe.
None of the patients in the best supportive care group had to withdraw from treatment because of their side effects, however 18.2% of those who received Tecentriq did.
More analyses of DFS and overall survival data are expected to continue as more data are collected over time.
“For the first time, we are seeing that an immunotherapy is effective when used to treat early-stage lung cancer. The IMpower010 trial demonstrates that, for certain patients, (Tecentriq) can delay progression to advanced disease, and perhaps even the need for more aggressive therapy. This could be an important advance in our understanding of immunotherapy and a step forward for many patients with lung cancer” noted ASCO chief medical officer and executive vice president Dr. Julie R. Gralow in the release.
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