ASCO Annual Meeting

ASCO Annual Meeting

Perspective from Bing Xia, MD
Source:

Wakelee HA, et al. Abstract 8500. Scheduled for presentation at: ASCO Annual Meeting (virtual meeting); June 4-8, 2021.

Disclosures: Wakelee reports advisory board roles with and/or consultant fees from AstraZeneca, Blueprint Medicines, Daiichi Sankyo, Helsinn, Janssen, Mirati and Xcovery; uncompensated consultant roles with Genentech/Roche and Merck; and research funding paid to her institution by ACEA Biosciences, Arrys Therapeutics, AstraZeneca/Medimmune, Bristol Myers Squibb, Celgene, Clovis Oncology, Genentech/Roche, Merck, Novartis, Pharmacyclics, Seagen and Xcovery. Please see the abstract for all researchers’ relevant financial disclosures.
May 20, 2021
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Adjuvant atezolizumab extends DFS in early-stage NSCLC

Perspective from Bing Xia, MD
Source:

Wakelee HA, et al. Abstract 8500. Scheduled for presentation at: ASCO Annual Meeting (virtual meeting); June 4-8, 2021.

Disclosures: Wakelee reports advisory board roles with and/or consultant fees from AstraZeneca, Blueprint Medicines, Daiichi Sankyo, Helsinn, Janssen, Mirati and Xcovery; uncompensated consultant roles with Genentech/Roche and Merck; and research funding paid to her institution by ACEA Biosciences, Arrys Therapeutics, AstraZeneca/Medimmune, Bristol Myers Squibb, Celgene, Clovis Oncology, Genentech/Roche, Merck, Novartis, Pharmacyclics, Seagen and Xcovery. Please see the abstract for all researchers’ relevant financial disclosures.
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Atezolizumab after surgery and chemotherapy reduced risk for disease recurrence or death among patients with stage II to stage IIIA non-small cell lung cancer, according to research presented during the virtual ASCO Annual Meeting.

Patients with tumors that expressed PD-L1 demonstrated a particularly pronounced DFS benefit with adjuvant atezolizumab (Tecentriq, Genentech) compared with best supportive care, results of the IMpower010 trial showed.

Atezolizumab after surgery and chemotherapy reduced risk for disease recurrence or death among patients with stage II to stage IIIA non-small cell lung cancer.
Data were derived from Wakelee HA, et al. Abstract 8500. Presented at: ASCO Annual Meeting (virtual meeting); June 4-8, 2021.

“This is the first immune checkpoint inhibitor to show a DFS benefit in a randomized, phase 3 trial in early-stage NSCLC,” Heather A. Wakelee, MD, thoracic specialist, professor of medicine and chief of the division of oncology at Stanford University Medical Center, told Healio.

Heather A. Wakelee, MD
Heather A. Wakelee

“Despite dramatic improvements in treatment for advanced-stage NSCLC, including targeted therapy and immune therapy, little progress has been made in treating early-stage lung cancer since the positive chemotherapy trials 15 years ago,” she added. “EGFR-targeted therapy can improve DFS for patients with tumors with EGFR mutations, but the vast majority of patients have no option other than chemotherapy. We hoped that the use of atezolizumab would improve outcomes for patients with early-stage NSCLC as it has for those with advanced-stage NSCLC.”

Wakelee and colleagues enrolled 1,280 patients with stage IB to stage IIIA NSCLC and an ECOG performance status of 0 to 1 who underwent complete resection 4 to 12 weeks prior to enrollment. Of them, 1,269 received up to four 21-day cycles of cisplatin-based chemotherapy with pemetrexed, docetaxel, gemcitabine or vinorelbine. Following chemotherapy, researchers randomly assigned 1,005 patients 1:1 to 16 cycles of 1,200 mg atezolizumab every 3 weeks or best supportive care.

Researchers evaluated DFS, the study's primary endpoint, and OS, the study's secondary endpoint, hierarchically: first, DFS among patients with stage II to stage III disease and PD-L1 expression on at least 1% of tumor cells (atezolizumab, n = 248; best supportive care, n = 228); second, DFS among patients with stage II to stage IIIA disease (atezolizumab, n = 442; best supportive care, n = 440); third, DFS among the intent-to-treat population (atezolizumab, n = 507; best supportive care, n = 498); and last, OS among the intent-to-treat population.

Median follow-up was 32.8 months (range, 0.1-57.5) in the intent-to-treat population.

The results showed atezolizumab, when compared with best supportive care, reduced the risk for recurrence or death by 34% among patients with stage II to stage IIIA disease whose tumors had PD-L1 expression of at least 1% (median DFS, not evaluable vs. 35.3 months; HR = 0.66; 95% CI, 0.5-0.88).

Among all patients with stage II to stage IIIA disease, atezolizumab reduced the risk for recurrence or death by 21% vs. best supportive care (median DFS, 42.3 months vs. 35.3 months; HR = 0.79; 95% CI, 0.64-0.96). The difference in DFS among the intent-to-treat population had not crossed the boundary for statistical significance (median, not evaluable vs. 37.2 months).

OS data had not yet matured and had not been formally tested, Wakelee said.

“Atezolizumab given after surgery and chemotherapy has a more profound effect on DFS among patients with stage II to stage IIIA NSCLC with PD-L1-expressing tumors than the benefit seen with chemotherapy among all-comers in the trials 15 years ago,” Wakelee said. “PD-L1 expression should be examined in all patients after surgical resection with consideration for use of adjuvant atezolizumab — once it is approved in this setting — for patients with tumors that express PD-L1. Over 50% of resected tumors that were tested for PD-L1 expressed PD-L1, so this treatment may be an option for a large percentage of patients with resected early-stage NSCLC.”

Researchers identified no new safety signals, according to Wakelee. Grade 3 to grade 4 adverse events occurred among 21.8% of 495 patients who had at least one dose of atezolizumab and 11.5% of 495 patients in the best supportive care cohort who had at least one post-baseline assessment. Researchers discontinued treatment for 18.2% of patients in the atezolizumab group because of toxicity.

Wakelee said the study continues to examine OS and DFS among all enrolled patients, including those with stage IB NSCLC, who represent only 12% of patients on the trial.

“There [also] is ongoing work looking at using atezolizumab and other immune therapy prior to surgery,” Wakelee told Healio. “Biomarker testing is important to allow us to give optimal adjuvant therapy to patients. Biomarker testing includes looking for EGFR mutations and now also for PD-L1 expression.”