KEY TAKEAWAYS
- The phase 2 trial aimed to explore anlotinib + penpulimab synergy in second-line SCLC post platinum-based therapy pts for improved outcomes.
- The primary endpoint was to evaluate antitumor activity by assessing the ORR.
- The result demonstrated that penpulimab + anlotinib offers clinical benefits and a favorable safety profile in sSCLC pts after platinum-based chemo.
Researchers in the Phase II ALTER1202 trial have unveiled promising results, showcasing a significant advancement in the treatment landscape for small-cell lung cancer (SCLC) patients (pts) who have faced the challenges of two or more unsuccessful systemic chemotherapy (chemo) regimens. Patients administered anlotinib post-treatment exhibited notable enhancements in progression-free survival (PFS) and overall survival (OS) compared to those in the placebo group.
To offer improved outcomes for individuals who have exhausted their options with first-line platinum-based chemo, Yongchang Zhang and his research group have explored the synergistic potential of combining anlotinib with penpulimab—an innovative PD-1 inhibitor. This exciting avenue of investigation holds the promise of a more effective and tailored approach to address the needs of pts in this challenging clinical context.
In this interventional open-label, single-arm, multi-center trial, they recruited pts with SCLC who had previously undergone platinum-based chemo. The treatment regimen comprised penpulimab (200mg every three weeks) and anlotinib (dose of 10mg), following a 2-week on and 1-week off schedule. Patients continued this combination therapy until disease progression, unacceptable toxicity, or study discontinuation.
The primary objective centered on evaluating antitumor activity using RECIST v1.1 criteria, with a specific focus on determining the objective response rate (ORR). Secondary objectives were to assess antitumor activity through parameters such as the disease control rate (DCR), duration of response (DOR), PFS, OS, and evaluating the safety and tolerability profile of the combined penpulimab and anlotinib therapy.
About 38 pts were evaluated using RECIST criteria, which revealed an ORR of 26.30% (10 out of 38) and a DCR of 68.42% (26 out of 38). The PFS was 4.36 months, with 6-month and 12-month PFS rates of 21.05% and 10.53%, respectively. The median DOR was 8.03 months, and the median OS was 15.71 months. Among the participants, 26 out of 38 (68.42%) experienced treatment-related adverse events (TRAEs), with 10 pts (26.32%) reporting grade 3 or higher AEs. The most commonly observed AEs associated with anlotinib were hepatic injury, hematoxicity, and hypertension.
The result showed that the use of penpulimab and anlotinib demonstrated encouraging clinical advantages and a favorable safety profile among pts with SCLC following treatment with platinum-based chemo.
This study is sponsored by Hunan Cancer Hospital.
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/34
Clinical Trial: https://clinicaltrials.gov/study/NCT05001971
Zhang Y, et al. “Efficacy and biomarker exploration of Anlotinib plus Penpulimab for extensive stage Small cell lung cancer who failed from previous Platinum-Based Chemotherapy: Result from A phase II perspective trials” Presented at ESMO IO 2023. (Abstract: 13P).
