KEY TAKEAWAYS
- The phase 2 LCMC3 study examined the effects of neoadjuvant chemoimmunotherapy (IO) treatment with or without adjuvant therapy on pts with early-stage NSCLC.
- The study primary endpoint was the MPR rate in pts without EGFR/ALK mutations.
- Neoadjuvant atezo (anti-PD-L1) treatment without adjuvant treatment resulted in impressive DFS outcomes, but the impact of adjuvant IO after neoadjuvant IO was not clear.
- The study updated data on DFS, OS, and safety in pts who received adjuvant atezo compared to those who did not.
The study recruited eligible patients (pts) aged above or equal to 18 years with resectable stage IB-IIIA or select IIIB NSCLC with ECOG PS 0-1. The pts administered neoadjuvant atezolizumab 1200 mg IV for up to two cycles (Days 1 and 22), followed by surgery (Day 40 ± 10). Those who did not experience progression could receive adjuvant atezolizumab every three weeks for up to 12 months. The study’s primary endpoint was the MPR rate (≤10% viable tumor cells at surgery) in pts without EGFR/ALK mutations. The study also included DFS and OS as exploratory endpoints, and safety was assessed during the adjuvant phase.
As of the data cutoff on October 21, 2022, the primary efficacy population (PEP) comprised 137 pts who underwent surgery and MPR assessment and did not have EGFR/ALK alterations. The entire group’s updated 3-year DFS and OS rates were 72% and 82%; for stage I/II 75% and 82%, and for stage III was 68% and 81%, respectively. The PEP study revealed 53 pts (39%) administered adj atezo, while 84(61%) did not. Although the groups were not randomized, they were clinically well-balanced. The pts who received adj atezo had higher 3-year disease-free survival rates than those who did not. The rates were 83% and 64% (HR, 0.48; 95% CI: 0.20, 1.12; P = 0.088), and 3-y OS was 87% vs 75% (HR, 0.49; 95% CI: 0.17, 1.46; P = 0.202) out of the pts who received adj atezo (n=57), 11 experienced treatment-related adverse events (19%; Gr 3/4, 16%), resulting in discontinuation of adj atezo.
The analysis demonstrated that pts with resectable NSCLC who utilized atezo as an adjunct experienced significant progress in DFS and a clear trend toward improved OS compared to those who did not. A similar trend towards enhanced DFS and OS with atezo as an adjunct was observed in the subgroup without MPR. Most importantly, atezo as an adjunct was well-received and did not result in any new safety issues. This undeniably suggests that incorporating IO as an adjunct to neoadj IO can lead to better results.
Source: https://oncologypro.esmo.org/meeting-resources/european-lung-cancer-congress/updated-survival-efficacy-and-safety-of-adjuvant-adj-atezolizumab-atezo-after-neoadjuvant-neoadj-atezo-in-the-phase-ii-lcmc3-study
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02927301
Carbone, D., Waqar, S.N., Chaft, J., Kris, M., Johnson, B., Lee, J., Wistuba, I., Kwiatkowski, D.J., Bunn, P.A., Schulze, K., Johnson, A., Brandao, E., Awad, M., Reckamp, K., Chiang, A.C., Nicholas, A., Rusch, V.W., Brotto, K. Journal of Thoracic Oncology (2023) rsion=”1.0″ encoding=”utf-8″?>
