523P - Camrelizumab plus apatinib as maintenance treatment in patients with extensive-stage small cell lung cancer who were responding or stable after standard first-line chemotherapy (CAMERA): Results from a single-arm, phase II trial

Background

Chemo-immunotherapy is the standard first-line (1L) therapy for patients (pts) with extensive-stage small cell lung cancer (ES-SCLC). However, not all ES-SCLC pts benefit from chemo-immunotherapy. We aimed to assess the efficacy and safety of camrelizumab + apatinib as maintenance treatment for ES-SCLC pts who had disease control after standard 1L chemotherapy.

Methods

Key inclusion criteria were age 18-75 years, histologically or cytologically confirmed ES-SCLC, ECOG PS 0-1, no disease progression after 4∼6 cycles of standard 1L chemotherapy. Eligible pts received camrelizumab (200mg, iv, d1, q3w) + apatinib (250mg, po, qd) until disease progression or intolerable toxicity. The primary endpoint was progression free survival (PFS); key secondary endpoints included overall response rate (ORR), disease control rate (DCR) and safety.

Results

From July 2021 to July 2023, 18 pts who received at least 1 dose of camrelizumab + apatinib were analyzed. The median age was 59 years (range: 45-75) with 16 (88.9%) males, 11 (61.1%) former smokers, 4 (22.2%) current smokers and 13 (72.2%) with ECOG PS 1. One patient (5.6%) had brain metastasis, 3 (16.7%) had liver metastasis, and 4 (22.2%) had bone metastasis. At data cutoff, 5 pts remained on treatment, and 16 pts had at least 1 post-treatment tumor assessment. The median PFS was 6.4 months (3.0-NR), the confirmed ORR and DCR were 12.5% (2/16) and 100% (16/16), respectively. Treatment-related adverse events (TRAEs) were reported in 17 pts (94.4%). Among them, 10 (55.6%) pts experienced grade 3 or 4 TRAEs. This included 2 pts (11.1%) with diarrhea, 2 (11.1%) with hyperglycemia, and 1 patient each (5.6%) with increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocyte count, pancreatitis, hyponatremia, asthenia, elevated γ-glutamyl transferase and nerve injury. No grade 5 adverse events occurred.

Conclusions

Camrelizumab plus apatinib had promising efficacy and acceptable safety as maintenance treatment in ES-SCLC pts who responded or had stable disease after standard 1L chemotherapy. Further validation is warranted.

Clinical trial identification

NCT04901754.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.