533P - Efficacy in the elderly NSCLC patients in SCORPION study: Phase II study of DTX plus RAM following platinum-based chemotherapy plus ICIs

Background

Docetaxel (DTX) + ramucirumab (RAM) is one of the standard treatment options in second-line setting after first-line platinum-based chemotherapy plus ICI. The SCORPION study, phase II trial evaluating the efficacy and safety of DTX plus RAM after first-line platinum-based chemotherapy plus ICI, demonstrated encouraging antitumor activity with a manageable safety profile. However, the clinical benefit of RAM in elderly patients is not fully elucidated. Here, we report the subset analysis of the elderly patients in SCORPION study.

Methods

The primary end point of the study was objective response rate (ORR), and secondary endpoints were disease control rate (DCR), progression-free survival (PFS), and safety etc. Patients were treated with 60 mg/m² of DTX and 10 mg/kg of RAM on day 1 with strong recommendation of pegfilgrastim on day 2 every 3 weeks.

Results

Thirty-three patients were recruited from 8 institutions. Median age (range) was 66 (42–79) y, 15 patients (45%) were aged ≤ 65, while 6 (18%) were aged ≥ 75. As previously reported, the primary endpoint was met as 11 of 32 patients achieved PR with ORR at 34.4% (80%CI, 23.1-47.2), and median PFS was 6.5 months. In elderly patients with aged ≥ 75 years, the ORR and disease control rate were 16.7 % and 100%, respectively (1 in 6 pts had a PR and all 6 pts had their disease controlled). Median PFS was 8.5 months. No treatment-related deaths and no new safety signals were observed in elderly patients aged ≥ 75 years.

Conclusions

DTX plus RAM showed favorable DCR with 8.5 months of PFS in elderly patients aged ≥ 75 years. Although our analysis was based on small subset, DTX plus RAM could be a treatment option even in elderly patients who failed first-line platinum-based chemotherapy plus ICI.

Clinical trial identification

jRCTs041190077.

Editorial acknowledgement

Legal entity responsible for the study

Masahiro Morise.

Funding

Eli Lilly Japan K.K.

Disclosure

T. Yamaguchi: Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceutical, Chugai Pharmaceutical, Eli Lilly, Taiho Pharmaceutical, AstraZeneca, MSD, Bristol-Myers Squibbb. R. Matsuzawa: Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim, AstraZeneca, Pfizer, Eli Lilly, Chugai Pharmaceutical, MSD, Ono Pharmaceutical, Taiho Pharmaceutical. M. Morise: Financial Interests, Institutional, Research Grant: Boehringer Ingelheim, Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly, Chugai, AstraZeneca, Ono, Pfizer, MSD; Non-Financial Interests, Personal, Non financial benefits: F. Hoffmann-La Roche; Financial Interests, Institutional, Local PI: Chugai, AstraZeneca, Ono, Pfizer, Merk Serono, Kissei, Taiho, Novartis. K. Ito: Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim, AstraZeneca, Pfizer, Eli Lilly, Chugai Pharmaceutical, MSD, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, Daiichi Sankyo. O. Hataji: Financial Interests, Institutional, Research Grant: AstraZeneca, Novartis, MSD, Daiichi Sankyo, Bayer Yakuhin, AbbVie, Eli Lilly, Janssen, Ono; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Chugai, Takeda, MSD, Merck, Daiichi Sankyo, Eli Lilly, AbbVie, Boehringer Ingelheim, Nippon Kayaku, Taiho. K. Takahashi: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Boehringer Ingelheim, Chugai, Eli Lilly, GSK, MSD, Nippon Kayaku, Novartis, Pfizer, Taiho, Takeda. Y. Goto: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical CO., LTD, Nippon Boehringer Ingelheim CO., LTD., Chugai Pharmaceutical CO., LTD., Chugai Pharmaceutical CO., LTD., MSD K.K., AstraZeneca K.K., GSK K.K., Pfizer Japan Inc., Takeda Pharmaceutical CO., LTD., Nippon Kayaku Co., Ltd., Novartis Japan, Bristol Myers Squibb K.K., KYOWA HAKKO BIO CO., Ltd., Eli Lilly Japan K.K. H. Itani: Financial Interests, Personal, Speaker’s Bureau: Eli Lilly. Y. Zenke: Financial Interests, Personal, Invited Speaker: AstraZeneca, Lilly, Chugai, Boehringer Ingelheim, Ono pharmaceutical, Bristol Myers Squibb, Takeda pharmaceutical, Taiho pharmaceutical, MSD, Novartis, Nippon Kayaku, Amgen, Kyowa-Hakko Kirin; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: AstraZeneca, MSD, Merck, Daiichi Sankyo, Amgen. M. Oki: Financial Interests, Institutional, Research Grant: AbbVie, Chugai, GSK, MSD, Parexel, Sanofi, AstraZeneca, Fujifilm Toyama Chemical, Janssen, Ono and Pfizer; Financial Interests, Personal, Speaker’s Bureau: AMCO, Canon Medical Systems, Fujifilm Toyama Chemical, Merit Medical Japan, Olympus, AstraZeneca, Chugai, Kaneka Medix, Novartis, and Sanofi. M. Ishii: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, GSK, Pfizer, Shionogi, Sanofi, Insmed, Asahi Kasei Pharma, Kyorin pharmaceutical, Chugai pharmaceutical, Boehringer Ingelheim, Eli Lilly, Daiichi Sankyo, MSD, Abbott, Taiho pharmaceutical, Amgen, Novartis. All other authors have declared no conflicts of interest.