Atezolizumab regimen ‘merits further study’ for unresectable NSCLC
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Key takeaways:
- Researchers noted a 12-week disease control rate of 74.2%.
- Nearly three-quarters of patients remained alive at 24 months.
Neoadjuvant atezolizumab prior to chemoradiation therapy exhibited promising activity for patients with unresectable stage III non-small cell lung cancer, according to results of a nonrandomized phase 2 study.
Researchers cited favorable results in key efficacy outcome measures, including 12-week disease control rate and PFS.
“The findings ... show that atezolizumab administration before and after standard [chemoradiation therapy] for patients with unresectable stage III NSCLC was safe and appeared to be effective,” Helen J. Ross, MD, director of research and clinical trials at RUSH Cancer Center, and colleagues wrote. “Based on the favorable outcomes, neoadjuvant atezolizumab therapy merits further study in this patient population.”
Treatment with durvalumab (Imfinzi, AstraZeneca) after chemoradiation therapy conferred a 10 percentage point improvement in OS compared with placebo for patients with unresectable stage III NSCLC.
Ross and colleagues conducted the single-cohort AFT-16 trial to assess outcomes among patients treated with atezolizumab (Tecentriq, Genentech) before and after chemoradiation therapy.
The trial included 62 treatment-naive patients (median age, 63.9 years; 51.6% women) with unresectable stage III NSCLC.
Patients received four 21-day cycles of 1,200 mg IV atezolizumab administered on day 1 of each cycle. Patients who did not experience tumor progression received chemoradiation therapy (60 Gy) concurrent with weekly carboplatin area under the curve 2 and 50 mg/m2 paclitaxel, followed by planned consolidation with carboplatin area under the curve 6 and paclitaxel 200 mg/m2 for two 21-day cycles.
Patients who still did not experience progression continued to receive 1,200 mg atezolizumab every 21 days until they reached 1 year of therapy.
Disease control rate at 12 weeks served as the primary endpoint. Secondary endpoints included PFS, OS, overall response rate and safety.
All 62 patients received at least one dose of atezolizumab.
Researchers reported a disease control rate at 12 weeks of 74.2% (80% CI, 65.7-81.4) and median PFS of 30 months (95% CI, 15.8 to not evaluable).
Median OS had not been reached. However, researchers reported a 24-month OS rate of 73.7% (95% CI, 63.4-85.7) and an ORR of 66.2%.
Seventeen patients (27.4%) experienced grade 3 or higher immune-related adverse events, including one with grade 5 pneumonitis and one with grade 4 Guillain-Barré syndrome.
Thirty patients (48.4%) experienced grade 3 or higher treatment-related adverse events.
Researchers acknowledged study limitations, including lack of a simultaneous control group.
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