1294P - A final analysis of a phase II study of durvalumab immediately after completion of chemoradiotherapy in unresectable stage III non–small-cell lung cancer: TORG1937 (DATE study)

Background

The best timing of starting durvalumab after completion of concurrent chemoradiation (CCRT) for patients with unresectable stage III non-small cell lung cancer (NSCLC) has not been identified. The study was conducted to evaluate the efficacy and safety of durvalumab administered immediately after completion of CCRT in patients with unresectable stage III NSCLC.

Methods

This study was a prospective, single-arm, multicenter, phase II clinical trial. Eligible Patients with ECOG PS 0,1, and age < 75 years old were enrolled and received definitive CCRT (2 cycles of platinum-based doublet chemotherapy with 60 Gy/30 Fr radiotherapy) followed by durvalumab (every 2 weeks for up to 12 months) from the next day (up to 5 days) after last radiation. The primary endpoint was 1-year progression-free survival (PFS) rate from registration as assessed by an independent review committee (IRC). Safety, objective response rate, 1-year PFS from start of durvalumab, PFS, 2-year PFS rate, 1-year and 2-year OS, and OS from registration and start of durvalumab were also evaluated. The efficacy according to the PD-L1 expression level was investigated as exploratory analysis. We present the updated final results of safety, efficacy and exploratory analysis.

Results

From January 2020 to August 2020, 50 patients were enrolled from 16 institutions and 47 patients were evaluable for efficacy and safety. Forty-two patients received durvalumab consolidation. PD-L1 expression levels were confirmed in 40 patients (tumor proportion score ≥ 50% in 19 patients, 1-49% in 11 patients, and <1% in 10 patients). The 1-year PFS rate from registration by IRC was 75.0% (60% CI: 69.0 to 80.0). Median PFS from registration was 20.8 months (95% CI: 14.9 to not reached), 2-year PFS rate was 48.6%, median OS was not reached, and 2-year OS rate was 84.5%. No unexpected adverse events and treatment-related deaths were observed. The 2-year PFS rate and 2-year OS was 40.0% and 80.0% for PD-L1-negative patients.

Conclusions

Our data support the efficacy and safety of durvalumab administered immediately after completion of CCRT for patients with unresectable stage III NSCLC.

Clinical trial identification

jRCTs031190117, 2019/10/15.

Editorial acknowledgement

Legal entity responsible for the study

Thoracic Oncology Research Group, Japan

Funding

AstraZeneca.

Disclosure

T. Kondo: Financial Interests, Personal, Invited Speaker: Daiichi Sankyo, AstraZeneca, Otsuka, Taiho Pharmaceutical, Ono Pharmaceutical; Financial Interests, Institutional, Local PI: AstraZeneca, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol Myers Squibb, Taiho Pharmaceutical, AbbVie, Amgen, Eli Lilly, Novartis Pharma, Pfizer, Regeneron, Merck BioPharma, Blueprint Medicine, BeiGene, Daiichi Sankyo, Turning Point, Haihe Biopharma, Janssen Pharma, Takeda Pharmaceutical, Sanofi. K. Kubota: Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb Japan, Chugai Pharma, Lilly Japan, MSD Oncology, Nihonkayaku, Pfizer, Taiho Pharma, Takeda, Shionogi, Ono Pharma, Merk-Biopharma, Kyowa Kirin; Financial Interests, Institutional, Trial Chair: Nihonkayaku, AstraZeneca. S. Nakamichi: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, AstraZeneca, Chugai Pharmaceutical, Bristol Myers Squibb, Ono Pharmaceutical, MSD, Takeda Pharmaceutical. S. Murakami: Financial Interests, Personal, Invited Speaker: AstraZeneca, Pfizer, Chugai Pharmaceutical, MSD, Ono Pharmaceutical, Takeda Pharmaceutical, Eli Lilly Japan, Bristol Myers Squibb, Boehringer Ingelheim, Merck BioPharma; Financial Interests, Institutional, Local PI: AstraZeneca, Chugai Pharmaceutical, Daiichi Sankyo, Ono Pharmaceutical, Janssen Pharmaceutical, Sanofi, MSD. Y. Shiraishi: Financial Interests, Personal, Invited Speaker: Chugai Pharma, Ono Pharmaceutical, Bristol Myers Squibb Company, AstraZeneca, Taiho Pharmaceutical; Financial Interests, Institutional, Local PI: Chugai Pharma; Non-Financial Interests, Principal Investigator: Chugai Pharma. D. Harada: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical Co., Ltd., AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Eli Lilly and Company, Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb Company, Towa Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited.; Financial Interests, Institutional, Local PI: MSD K.K.; Financial Interests, Institutional, Funding: Chugai Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., AstraZeneca K.K., Taiho Pharmaceutical Co., Ltd., MSD K.K., Eli Lilly and Company; Non-Financial Interests, Project Lead, a primary investigator of OLCSG2001 trial: OLCSG; Non-Financial Interests, Leadership Role: JSMO. H. Itani: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K.; Financial Interests, Institutional, Funding: Chugai Pharmaceutical Co., Ltd. H. Wakui: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai Pharma, Daiichi Sankyo, Eli Lilly, Kyowa Kirin, MSD, Nippon Kayaku, Ono Pharma, Pfizer, Taiho Pharma, Takeda Pharma, UCB. S. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Ono, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Ono, Bristol Myers Squibb, Taiho, Eli Lilly, Pfizer, Boehringer Ingelheim, Takeda; Financial Interests, Research Grant: AstraZeneca, Chugai. T. Asao: Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Merck Biopharma, MSD, Nippon Kayaku, Ono Pharmaceutical, Pfizer, Taiho, Takeda; Financial Interests, Institutional, Local PI: Chugai Pharmaceutical, Ono. N. Furuya: Financial Interests, Personal, Invited Speaker: Eli Lilly Japan, AstraZeneca, Boehringer Ingelheim Japan, Chugai, Bristol Myers Squibb, Taiho, Pfizer Japan, Novartis. Y. Takiguchi: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, AstraZeneca, Chugai Pharma, Boehringer Ingelheim, Daiichi Sankyo, Taiho Pharmaceutical, Bristol Myers Squibb Japan, Lilly, Pfizer, Novartis, Kyowa Kirin International, MSD, Eisai, Takeda, Amgen; Financial Interests, Personal, Other, Member of Ethics Committee: Oncolys BioPharma; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim, Lilly, Chugai Pharma, Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: MSD Oncology, AstraZeneca, AbbVie. H. Okamoto: Financial Interests, Institutional, Research Grant: MSD, Taiho, Bristol Myers Squibb. All other authors have declared no conflicts of interest.