Abstract
The PD-1 antibody camrelizumab plus the VEGFR2 inhibitor apatinib had efficacy in a phase II trial.
Major Finding: The PD-1 antibody camrelizumab plus the VEGFR2 inhibitor apatinib had efficacy in a phase II trial.
Concept: Many cervical cancers express PD-L1 and depend on angiogenesis-promoting factors such as VEGF.
Impact: This work shows that immunotherapy plus VEGFR inhibition is of interest in advanced cervical cancer.
Second-line treatment options are limited for patients with advanced cervical cancer, and the prognosis for patients with disease that initially resists or recurs following first-line platinum-based chemotherapy regimens is poor. Most squamous-cell carcinomas of the cervix (representing the most common histologic subtype of cervical cancer) express PD-L1, and preclinical studies have suggested that angiogenesis-inhibiting drugs may be of use in this malignancy. On this basis, Lan and colleagues initiated an open label, single-arm, phase II clinical trial of the PD-1 antibody camrelizumab plus the VEGFR2 inhibitor apatinib in 45 patients with metastatic, recurrent, or persistent cervical cancer whose disease had progressed after treatment with at least one line of systemic anticancer therapy. Among the 41 patients whose disease was evaluable for treatment efficacy, the overall response rate was 55.6%, with 4.4% complete responses and 51.1% partial responses. Additionally, 29.3% of these patients experienced stable disease. After a median follow-up period of 11.3 months, the median duration of response was not reached, nor was the median overall survival; however, the median progression-free survival was 8.8 months. Safety was evaluable among all 45 enrolled patients, 95.6% of whom experienced at least one treatment-related adverse event (TRAE), and 71.1% experienced grade 3 or 4 TRAEs, most commonly hypertension, anemia, and fatigue, but no treatment-related deaths occurred. TRAEs that may have been immune-mediated and could have been caused by camrelizumab, the most common of which was hypothyroidism, were observed in 33.3% of patients. In summary, the results of this phase II trial, the first to combine anti–PD-1 with a VEGFR inhibitor in patients with advanced cervical cancer, provides promising early evidence of efficacy and suggests that treatment-associated toxicities are manageable.
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