Success for serplulimab plus chemotherapy in small cell lung cancer

Serplulimab plus chemotherapy delivered consistent clinical benefits over chemotherapy alone in the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC), with a manageable safety profile.

“There is still a huge unmet medical need for patients with SCLC,” stated Prof. Ying Cheng (Jilin Cancer Hospital, China). In the pivotal ASTRUM-010 study, the novel PD-1 inhibitor serplulimab demonstrated encouraging anti-tumour activity and a manageable safety profile in patients with microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumours [1]. Prof. Cheng presented the primary results of the phase 3 ASTRUM-005 trial (NCT04063163; n=585), which randomised patients with previously untreated ES-SCLC 2:1 to serplulimab plus chemotherapy or placebo plus chemotherapy [2]. The primary endpoint was overall survival (OS).

After a median follow-up of 12.3 months, patients on serplulimab had a significant OS benefit over patients on placebo (median OS 15.4 vs 10.9 months; HR 0.63; P<0.001; see Figure). This result was consistent across subgroups, including patients with various PD-L1 expression levels. Also, the median progression-free survival (5.7 vs 4.3 months; HR 0.48), overall response rates (80.2% vs 70.4%), and median duration of response (5.6 vs 3.2 months; HR 0.48) favoured serplulimab over placebo.

Figure: Overall survival of serplulimab plus chemotherapy versus placebo plus chemotherapy [2]



OS, overall survival; mo, month; NE, not estimable.

The safety profiles of the 2 treatment regimens were mostly comparable. Serious adverse events (AEs) were reported in 35% of the patients in both arms and treatment discontinuations were observed in 4.9% and 4.1% of the patients in the experimental and placebo arm, respectively. Immune-related AEs were more prevalent in the serplulimab group (37.0% vs 18.4%), with hypothyroidism (11.6%), hyperthyroidism (9.0%), and rash (3.1%) being the most commonly identified immune-related AEs in the experimental group.

This survival advantage of nearly 5 months is the highest of any Checkpoint inhibitor in this setting up to now. If confirmed, serplulimab could be the first PD-1 inhibitor in this setting and could outperform previously reported PD-L1 inhibitors.

1. Qin SK, et al. J Clin Oncol. 2021;39(15_suppl):2566–2566.
2. Cheng Y, et al. Serplulimab, a novel anti-PD-1 antibody, plus chemotherapy versus chemotherapy alone as first-line treatment for extensive-stage small-cell lung cancer: An international randomized phase 3 study. Abstract 8505, ASCO 2022 Annual Meeting, 3‒7 June, Chicago, IL, USA.

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Posted on 5 August, 202225 March, 2024