13P - 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

Background

The phase II ALTER1202 trial demonstrated that patients who received anlotinib after failing at least two systemic chemotherapy regimens exhibited improved progression-free survival (PFS) and overall survival (OS) compared to the placebo group. In an effort to further enhance outcomes for small-cell lung cancer patients who have exhausted first-line platinum-based chemotherapy options, researchers are investigating the combination of anlotinib and penpulimab, a novel PD-1 inhibitor.

Methods

This open-label, single-arm, multi-center, phase II exploratory study enrolled patients with small-cell lung cancer who had previously undergone platinum-based chemotherapy. Patients received a combination therapy consisting of penpulimab (200mg every three weeks) and anlotinib (10mg daily), following a 2-week on and 1-week off schedule, until disease progression, unacceptable toxicity, or study discontinuation. The primary objective was to assess antitumor activity using the RECIST v1.1 criteria, focusing on the objective response rate (ORR). Secondary objectives included evaluating antitumor activity through the disease control rate (DCR), duration of response (DOR), PFS, OS, and assessing the safety and tolerability of this combination therapy.

Results

As of September 17, 2023, 38 patients were enrolled in the study and had received treatment. Of these 38 patients, 38 were evaluable using RECIST criteria, revealing an ORR of 26.30% (10 out of 38) and a DCR of 68.42% (26 out of 38). The median 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 patients, 26 out of 38 (68.42%) experienced treatment-related adverse events, with 10 patients (26.32%) reporting grade 3 or higher adverse events. The most common adverse events related to anlotinib were hepatic injury, hematoxicity, and hypertension.

Conclusions

The combination of penpulimab and anlotinib showed promising clinical benefits and a favorable safety profile in small-cell lung cancer patients after platinum-based chemotherapy.

Clinical trial identification

NCT05001971.

Legal entity responsible for the study

Hunan Provincial Cancer Hospital.

Funding

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.