TY - JOUR
T1 - Avelumab Versus Docetaxel in Patients With Platinum-Treated Advanced NSCLC
T2 - 2-Year Follow-Up From the JAVELIN Lung 200 Phase 3 Trial
AU - Park, Keunchil
AU - Özgüroğlu, Mustafa
AU - Vansteenkiste, Johan
AU - Spigel, David
AU - Yang, James C.H.
AU - Ishii, Hidenobu
AU - Garassino, Marina
AU - de Marinis, Filippo
AU - Szczesna, Aleksandra
AU - Polychronis, Andreas
AU - Uslu, Ruchan
AU - Krzakowski, Maciej
AU - Lee, Jong Seok
AU - Calabrò, Luana
AU - Arén Frontera, Osvaldo
AU - Xiong, Huiling
AU - Bajars, Marcis
AU - Ruisi, Mary
AU - Barlesi, Fabrice
N1 - Publisher Copyright:
© 2021 International Association for the Study of Lung Cancer
PY - 2021/8/1
Y1 - 2021/8/1
N2 - Introduction: In the JAVELIN Lung 200 trial, avelumab (anti-programmed death-ligand 1 [PD-L1] antibody) did not significantly prolong overall survival (OS) versus docetaxel in patients with platinum-treated PD-L1+ NSCLC. We report greater than 2-year follow-up data. Methods: Patients with stage IIIB or IV or recurrent NSCLC with disease progression after platinum-doublet chemotherapy were randomized 1:1 to avelumab 10 mg/kg every 2 weeks or docetaxel 75 mg/m2 every 3 weeks. The primary end point was OS in patients with PD-L1+ tumors (greater than or equal to 1% tumor cell expression; IHC 73-10 pharmDx assay). Results: Of 792 patients, 529 had PD-L1+ tumors (264 versus 265 in the avelumab versus docetaxel arms, respectively). As of March 4, 2019, median duration of follow-up for OS in the PD-L1+ population was 35.4 months in the avelumab arm and 34.7 months in the docetaxel arm; study treatment was ongoing in 25 (9.5%) versus 0 patients, respectively. In the PD-L1+ population, 2-year OS rates (95% confidence interval [CI]) with avelumab versus docetaxel were 29.9% (24.5%–35.5%) versus 20.5% (15.6%–25.8%); in greater than or equal to 50% PD-L1+ subgroups, 2-year OS rates were 36.4% (29.1%–43.7%) versus 17.7% (11.8%–24.7%) and in the greater than or equal to 80% subgroup were 40.2% (31.3%–49.0%) versus 20.3% (12.9%–28.8%), respectively. Median duration of response (investigator assessed) was 19.1 months (95% CI: 10.8–34.8) versus 5.7 months (95% CI: 4.1–8.3). Safety profiles for both arms were consistent with the primary analysis. Conclusions: Although the JAVELIN Lung 200 primary analysis (reported previously) revealed that avelumab did not significantly prolong OS versus docetaxel in patients with platinum-treated PD-L1+ NSCLC, posthoc analyses at 2 years of follow-up revealed that 2-year OS rates were doubled with avelumab in subgroups with higher PD-L1 expression (greater than or equal to 50% and greater than or equal to 80%).
AB - Introduction: In the JAVELIN Lung 200 trial, avelumab (anti-programmed death-ligand 1 [PD-L1] antibody) did not significantly prolong overall survival (OS) versus docetaxel in patients with platinum-treated PD-L1+ NSCLC. We report greater than 2-year follow-up data. Methods: Patients with stage IIIB or IV or recurrent NSCLC with disease progression after platinum-doublet chemotherapy were randomized 1:1 to avelumab 10 mg/kg every 2 weeks or docetaxel 75 mg/m2 every 3 weeks. The primary end point was OS in patients with PD-L1+ tumors (greater than or equal to 1% tumor cell expression; IHC 73-10 pharmDx assay). Results: Of 792 patients, 529 had PD-L1+ tumors (264 versus 265 in the avelumab versus docetaxel arms, respectively). As of March 4, 2019, median duration of follow-up for OS in the PD-L1+ population was 35.4 months in the avelumab arm and 34.7 months in the docetaxel arm; study treatment was ongoing in 25 (9.5%) versus 0 patients, respectively. In the PD-L1+ population, 2-year OS rates (95% confidence interval [CI]) with avelumab versus docetaxel were 29.9% (24.5%–35.5%) versus 20.5% (15.6%–25.8%); in greater than or equal to 50% PD-L1+ subgroups, 2-year OS rates were 36.4% (29.1%–43.7%) versus 17.7% (11.8%–24.7%) and in the greater than or equal to 80% subgroup were 40.2% (31.3%–49.0%) versus 20.3% (12.9%–28.8%), respectively. Median duration of response (investigator assessed) was 19.1 months (95% CI: 10.8–34.8) versus 5.7 months (95% CI: 4.1–8.3). Safety profiles for both arms were consistent with the primary analysis. Conclusions: Although the JAVELIN Lung 200 primary analysis (reported previously) revealed that avelumab did not significantly prolong OS versus docetaxel in patients with platinum-treated PD-L1+ NSCLC, posthoc analyses at 2 years of follow-up revealed that 2-year OS rates were doubled with avelumab in subgroups with higher PD-L1 expression (greater than or equal to 50% and greater than or equal to 80%).
KW - Avelumab
KW - Non–small cell lung cancer
KW - PD-L1
KW - Phase 3
KW - Second-line
UR - http://www.scopus.com/inward/record.url?scp=85105584972&partnerID=8YFLogxK
U2 - 10.1016/j.jtho.2021.03.009
DO - 10.1016/j.jtho.2021.03.009
M3 - Article
C2 - 33845211
AN - SCOPUS:85105584972
SN - 1556-0864
VL - 16
SP - 1369
EP - 1378
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 8
ER -