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Lung Cancer—Non-Small Cell Local-Regional / Small Cell

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Lung Cancer—Non-Small Cell Local-Regional / Small Cell LUNG CANCER—NON-SMALL CELL LOCAL-REGIONAL/SMALL CELL/OTHER THORACIC CANCERS 8500 Oral Abstract Session IMpower010: Primary results of a phase III global study of atezolizumab versus best supportive care after adjuvant chemotherapy in resected stage IB-IIIA non-small cell lung cancer (NSCLC). Heather A. Wakelee, Nasser K. Altorki, Caicun Zhou, Tibor Cso}szi, Ihor O. Vynnychenko, Oleksandr Goloborodko, Alexander Luft, Andrey Akopov, Alex Martinez-Marti, Hirotsugu Kenmotsu, Yuh-Min Chen, Antonio Chella, Shunichi Sugawara, Barbara J. Gitlitz, Elizabeth Bennett, Fan Wu, Jing Yi, Yu Deng, Mark McCleland, Enriqueta Felip; Stanford University Medical Center, Stanford, CA; New York- Presbyterian Hospital, Weill Cornell Medicine, New York, NY; Tongji University Affiliated Shanghai Pul- monary Hospital, Shanghai, China; Ja�sz-Nagykun Szolnok Megyei Hete�nyi Ge�za Ko�rha�z-Rende- lointe�zet, Szolnok, Hungary; Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary, Sumy, Ukraine; MI Zaporizhzhia Regional Clinical Oncological Dispensary, Zaporizhzhya, Ukraine; Leningrad Regional Clinical Hospital, Saint-Petersburg, Russian Federation; Pavlov State Medical University, Saint-Petersburg, Russian Federation; Medical Oncology Department, Vall d�Hebron University Hospital/Vall d�Hebron Institute of Oncology (VHIO), Barcelona, Spain; Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan; Division of Thoracic Oncology, Department of Chest Medicine, Taipei Veterans General Hospital and Department of Medicine, National Yang-Ming University, Taipei, Taiwan; Unit of Pneumology, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy; Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan; Genentech, Inc, South San Francisco, CA; Roche China, Shanghai, China; Genentech, Inc., South San Francisco, CA; Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona, Spain Background: Adjuvant platinum-based chemotherapy (chemo) provides only a modest 5-year survival benefit in fully resected, high-risk early-stage NSCLC. We report the primary disease-free survival (DFS) results from the pre-planned interim analysis of IMpower010, a randomized phase 3 open-label trial of adjuvant atezolizumab (atezo; anti–PD-L1) vs best supportive care (BSC) after adjuvant chemo in pa- tients (pts) with early-stage resected NSCLC. Methods: Eligible pts had completely resected (4-12 weeks prior to enrollment) Stage IB ($4 cm)-IIIA NSCLC (AJCC/UICC v7) and ECOG PS 0-1. A total of 1280 pts were enrolled, and 1269 pts received up to four 21-day cycles of cisplatin-based chemo (plus pemetrexed, docetaxel, gemcitabine or vinorelbine). Of these pts (n=1269), 1005 were subsequently randomized 1:1 to 16 cycles of atezo 1200 mg Q3W or BSC. The primary endpoint of investigator-as- sessed DFS and secondary endpoint of overall survival (OS) were tested hierarchically: first DFS in the PD-L1 TC $1% (SP263) subgroup with Stage II-IIIA disease, then DFS in all randomized pts with Stage II-IIIA disease, then DFS in the ITT population (Stage IB-IIIA) and finally OS in the ITT population. Effi- cacy assessments were based on randomized pts. Safety was assessed in the safety-evaluable popula- tion, defined as pts who received $1 dose of atezo or who had $1 post-baseline safety assessment if randomized to the BSC arm. Results: At data cutoff (January 21, 2021), median follow-up was 32.2 months in the ITT population. Baseline characteristics were generally balanced between arms. Atezo showed statistically significant DFS benefit vs BSC in the PD-L1 TC $1% Stage II-IIIA and all random- ized Stage II-IIIA populations; the significance boundary was not crossed for DFS in the ITT population (Table). OS data were immature and not formally tested. Pts in the atezo arm received a median of 16 (range, 1-16) atezo doses. Any-grade AEs occurred in 92.7% (atezo) and 70.7% (BSC); events were Grade 3/4 in 21.8% and 11.5%, respectively. Grade 5 treatment-related AEs occurred in 0.8% of pts in the atezo arm. AEs leading to atezo discontinuation occurred in 18.2% of atezo-treated pts. Conclu- sions: IMpower010 met its primary endpoint, showing DFS benefit with adjuvant atezo vs BSC after ad- juvant chemo in pts with resected Stage II-IIIA NSCLC, with pronounced benefit in the PD-L1 TC $1% subgroup. The safety profile of atezo was consistent with prior experience of atezo monotherapy across indications and lines of therapy. Funding: F. Hoffmann-La Roche Ltd. Clinical trial information: NCT02486718. Research Sponsor: F. Hoffmann-La Roche. PD-L1 TC $1% Stage II-IIIA All Randomized Stage II-IIIA ITT Atezo BSC Atezo BSC Atezo BSC (n=248) (n=228) (n=442) (n=440) (n=507) (n=498) Median DFS, mo NR 35.3 42.3 35.3 NR 37.2 Stratified HR (95% CI) 0.66 (0.50, 0.88) 0.79 (0.64, 0.96) 0.81 (0.67, 0.99)a 2-sided P value 0.0039 0.0205 0.0395 NR, not reached. aDid not cross significance boundary. © 2021 by American Society of Clinical Oncology. Visit abstracts.asco.org and search by abstract for disclosure information. LUNG CANCER—NON-SMALL CELL LOCAL-REGIONAL/SMALL CELL/OTHER THORACIC CANCERS 8501 Oral Abstract Session Adjuvant gefitinib versus cisplatin/vinorelbine in Japanese patients with completely resected, EGFR-mutated, stage II-III non-small cell lung cancer (IMPACT, WJOG6410L): A randomized phase 3 trial. Hirohito Tada, Tetsuya Mitsudomi, Takeharu Yamanaka, Kenji Sugio, Masahiro Tsuboi, Isamu Okamoto, Yasuo Iwamoto, Noriaki Sakakura, Shunichi Sugawara, Shinji Atagi, Toshiaki Takahashi, Hidetoshi Hayashi, Morihito Okada, Hiroshige Yoshioka, Hidetoshi Inokawa, Kazuhisa Takahashi, Masahiko Higashiyama, Ichiro Yoshino, Kazuhiko Nakagawa, West Japan Oncology Group; Suita To- kushukai Hospital, Suita, Japan; Department of Surgery, Kindai University Faculty of Medicine, Osaka- sayama, Japan; Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan; Department of Thoracic and Breast Surgery, Oita University Faculty of Medicine, Oita, Japan; Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Chiba, Japan; Kyushu University Hospital, Fukuoka, Japan; Department of Medical Oncology, Hiroshima City Hiroshi- ma Citizens Hospital, Hiroshima, Japan; Aichi cancer center, Nagoya, Japan; Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan; Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan; Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan; Kindai University Faculty of Medicine, Osaka, Japan; Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan; Kansai Medical University, Hirakata, Ja- pan; Yamaguchi-Ube Medical Center, Ube, Japan; Department of Respiratory Medicine, Juntendo Uni- versity School of Medicine, Tokyo, Japan; Department of Thoracic Surgery, Osaka Medical Center for Cancer and Cardivascular Diseases, Osaka, Japan; Department of General Thoracic Surgery, Chiba Uni- versity Graduate School of Medicine, Chiba, Japan; Kindai University Hospital, Osaka, Japan Background: Epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor is a standard of care for EGFR mutation-positive, untreated metastatic non-small cell lung cancer (NSCLC). However, the effi- cacy and safety of adjuvant gefitinib for patients with completely resected lung cancer harboring EGFR mutation over cisplatin-based adjuvant chemotherapy were not known in 2011 when this study was ini- tiated. Methods: From September 2011 to December 2015, we randomly assigned 234 patients with completely resected, EGFR mutation-positive (exon 19 deletion or L858R), stage II–III NSCLC to re- ceive either gefitinib (250 mg, once daily) for 24 months or cisplatin (80 mg/m2 on day 1) plus vinorel- bine (25 mg/m2 on days 1 and 8) (cis/vin) every 3 weeks for four cycles. The primary endpoint was disease-free survival (DFS) according to a central review in the intent-to-treat (ITT) population. Results: Two patients in the gefitinib arm withdrew consent and were excluded from the ITT population. No treat- ment-related deaths were seen in the gefitinib arm, but three treatment-related deaths were reported in the cis/vin arm. Median duration of follow-up was 71 months. Median DFS was numerically longer in the gefitinib arm (36 months) than in the cis/vin arm (25.2 months). However, Kaplan-Meier curves be- gan to overlap around 5 years after surgery, and no significant difference in DFS was seen, with a hazard ratio (HR) of 0.92 (95% confidence interval (CI), 0.67–1.28; P = 0.63). Overall survival was also not significantly different (median not reached in either arm). Five-year survival rates for gefitinib and cis/ vin arms were 78.0% and 74.6%, respectively, with an HR for death of 1.03; 95%CI, 0.65–1.65; P = 0.89. Exploratory subset analysis revealed that patients 370 years old in the gefitinib arm (n = 19/27 with G to cis/vin) survived longer than those in the cis/vin arm (HR 0.31; 95%CI, 0.10–0.98; P = 0.046). Conclusions: Adjuvant gefitinib appeared to prevent early relapse, but did not significantly pro- long DFS or OS in patients with completely resected stage II–III, EGFR-mutated NSCLC. The apparent non-inferiority of DFS/OS may justify the use of adjuvant gefitinib in selected subset of patients, espe- cially those deemed unsuitable for cis/vin adjuvant therapy.Clinical trial information: UMIN000006252. Research Sponsor: Astra-Zeneca. © 2021 by American Society of Clinical Oncology. Visit abstracts.asco.org and search by abstract
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