1292MO - A phase II study of daily carboplatin plus irradiation followed by durvalumab for unresectable III non-small cell lung cancer patients with PS 2 or elderly (≧75 years): NEJ039A

Background

Chemoradiotherapy followed by durvalumab consolidation therapy is standard care for patients with unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, it remains unclear about the clinical significance of durvalumab after chemoradiotherapy in patients with LA-NSCLC a performance status (PS) of 2 or aged ≥75 years.

Methods

Daily low-dose carboplatin (30 mg/m²) was administered to patients 1 h before radiotherapy for the first 20 fractions. Radiotherapy for all patients consisted of 60 Gy administered as 30 fractions. Durvalumab at a dose of 10 mg/kg was intravenously administered every 2 weeks for up to 12 months after chemoradiotherapy. The primary endpoint was the progression free survival rate (PFS) of 12 months from the initiation of durvalumab administration. The secondary endpoints included the rate of therapeutic completion, PFS, overall survival (OS), objective response rate (ORR), and safety.

Results

Of 86 patients who underwent induction chemoradiotherapy from September 2019 to October 2021, 61 (70.9%) received durvalumab consolidation therapy. A total of 61 patients (50 males, 11 females; median age 78y; range 55-89y) was eligible for the further analysis. The PS was 0, 1, and 2 in 28 (45.9%), 27 (44.3%), and 6 (9.8%) patients. Regarding PD-L1 expression, 14 (22.9%), 17 (27.9%), 17 (27.9%), and 13 (21.3%) patient displayed levels of ≥50%, 1–49%, <1%, and unknown, respectively. The PFS rate of 12 months from durvalumab start was 51.0% (90% confidence interval [CI], 39.9 to 61.1). Therefore, the current study met the primary endpoint. The ORR after chemoradiotherapy and durvalumab consolidation was 47.0% and 57.4%, respectively. The median PFS and OS were 12.3 and 28.1 months, respectively. The rate of therapeutic completion for durvalumab was 26.2%. The most common treatment related adverse event of grade 3 or 4 was pneumonitis (6.6%). One patient died because of grade 5 interstitial pneumonitis.

Conclusions

Durvalumab consolidation after daily carboplatin with radiotherapy was effective and tolerable for LA-NSCLC vulnerable patients.

Clinical trial identification

jRCTs031190070.

Editorial acknowledgement

Legal entity responsible for the study

North East Japan Study Group.

Funding

AstraZeneca.

Disclosure

R. Ko: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, Chugai Pharmaceutical, Eli Lilly, Boehringer Ingelheim, Pfizer, AstraZeneca, Ono Pharmaceutical, Daiichi Sankyo, Takeda, MSD; Financial Interests, Institutional, Research Funding: MSD, AstraZeneca. T. Nakagawa: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical , Eli Lilly Japan. N. Ishikawa: Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim GmbH, GSK. T. Kondo: Financial Interests, Personal, Invited Speaker: Daiichi Sankyo, AstraZeneca, Taiho Pharmaceutical, Ono Pharmaceutical Co., Ohtsuka; Financial Interests, Institutional, Research Funding: AstraZeneca, Chugai Pharmaceutical, Ono Pharmaceutical, AstraZeneca, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol Myers Squibb, Taiho Pharmaceutical, AbbVie, Amgen, Eli Lilly, Novartis Pharma, Pfizer, AstraZeneca, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol Myers Squibb, Abb Vie, Amgen, Eli Lilly, Novartis Pharma, Pfizer, Regeneron, Merk Bio Pharma, Blueprint Medicine, BeiGene, Daiichi Sankyo, Turning Point, HJaihe Biopharma, Janssen Pharma, Takeda Pharmaceutical, Sanofi. A. Bessho: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Research Funding: AstraZeneca. K. Yoshimura: Financial Interests, Personal, Invited Speaker: Chugai Pharma, AstraZeneca, Sysmex. H. Kagamu: Financial Interests, Personal, Research Funding: Boehringer Ingelheim GmbH; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai Pharmaceutical Co., Bristol-Myers Co.; Financial Interests, Personal, Stocks or ownership: ImmuniT Research Inc., Chemokine Technology Inc.; Financial Interests, Personal, Advisory Role: ImmuniT Research Inc. K. Kobayashi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Daiichi Sankyo Co, Takeda Pharmaceutical Co. K. Kaira: Financial Interests, Personal, Advisory Board: Ono Pharmaceutical Company, Boehringer Ingelheim, Chugai Pharmaceutical Co., Bristol Myers Company, AstraZeneca; Financial Interests, Institutional, Research Funding: AstraZeneca, Daiichi Sankyo Company, Eli Lilly Japan. All other authors have declared no conflicts of interest.