1468P - Patients’ perspective on tolerability of dostarlimab in NSCLC: Patient-reported outcomes from the phase II PERLA trial

Background

In the phase II double-blind PERLA trial (NCT04581824), dostarlimab + chemotherapy (DCT) showed similar efficacy to pembrolizumab + CT (PCT) as first-line treatment (tx) for patients (pts) with metastatic non-oncogene-driven, non-squamous, non-small cell lung cancer (NSCLC); the proportion of pts experiencing tx-related adverse events (TRAEs) or AEs leading to tx discontinuation was similar between groups [1]. Exploratory analyses of pt-reported measures of tolerability were conducted.

Methods

Eligible pts with ECOG 0–1 were randomized 1:1 to receive ≤35 cycles (C) of DCT or PCT every 3 weeks (Q3W) (CT: ≤35 C of 500 mg/m² pemetrexed + ≤4 C of cisplatin or carboplatin). Patient-reported outcome version of CTCAE (PRO-CTCAE) and the tolerability item of FACT-G (FACT-GP5) were collected at Day 1 C1, then Q3W to Week 12, Q9W to Week 48, Q12W to end of tx, at end of tx, and 30-day safety follow-up.

Results

Completion rates for PRO-CTCAE (DCT N=96/PCT N=88) and FACT-GP5 (DCT N=95/PCT N=87) were >80% up to C4, then decreased in both tx arms. At baseline (BL), only the urinate frequently item had >10% of pts reporting occurrence as “frequently” or greater per PRO-CTCAE (DCT: 11.5% [n=11/96]; PCT: 10.2% [n=9/88]); “severe” or greater severity and “quite a bit” or greater interference responses were reported in <10% of pts. At C13 (∼1 yr of tx) urinate frequently was similar between arms (“frequently” or greater in DCT: 12.5% [n=4/32]; PCT: 10% [n=2/20]). Relative to BL, at C13 muscle and joint ache frequency, severity and interference responses of “quite a bit” or greater were increased in both arms, but occurred in <16% of pts. Per FACT-GP5, at BL (i.e., before trial tx) 85.3/94.3% of DCT/PCT pts were “not at all” or “a little bit” bothered by tx side effects; at C13 this was 77.4/84.2% and no pts in either arm were “very much” bothered.

Conclusions

Most pts reported little or no bother from tx side effects and responses were similar across tx arms, suggesting interventions are tolerable from pt perspective. These results supplement previously reported PERLA data and support further investigation of dostarlimab combined with existing and novel therapies in metastatic NSCLC. 1. Peters S, et al. 2022; Oral; ESMO-IO (7–9 Dec, Geneva). Funding: GSK (213403).

Clinical trial identification

NCT04581824.

Editorial acknowledgement

Editorial support was provided by Claire Kelly, PhD, and Eva Kane, PhD, at Fishawack Indicia, UK, part of Fishawack Health Ltd and funded by GSK.

Legal entity responsible for the study

GSK.

Funding

Funding: GSK213362; NCT03329001.

Disclosure

M. Reck: Financial Interests, Personal, Advisory Role: Amgen, AstraZeneca, BeiGene, BMS, Boehringer Ingelheim, Daiichi Sankyo, GSK, Lilly, Merck, MSD, Novartis, Pfizer, Regeneron, Roche, Samsun Bioepsis, Sanofi. F. de Marinis: Financial Interests, Personal, Advisory Role: AstraZeneca, Roche, BMS, Novartis, Merck, Janssen. Q. Shen: Financial Interests, Personal, Full or part-time Employment: GSK; Financial Interests, Personal, Stocks/Shares: GSK. S.H. Boklage: Financial Interests, Personal, Full or part-time Employment: GSK; Financial Interests, Personal, Stocks/Shares: GSK; Financial Interests, Stocks/Shares: LLc. C. Dabrowski: Financial Interests, Personal, Full or part-time Employment: GSK; Financial Interests, Personal, Stocks/Shares: GSK. L. Cho: Financial Interests, Personal, Full or part-time Employment: GSK; Financial Interests, Personal, Stocks/Shares: GSK. O. Meyers: Financial Interests, Personal, Full or part-time Employment: GSK; Financial Interests, Personal, Stocks/Shares: GSK. All other authors have declared no conflicts of interest.