Fruquintinib (a highly selective VEGFR inhibitor) plus sintilimab (an anti-PD-1 monoclonal antibody) showed promising antitumor activity in both pre-clinical and clinical studies.

The primary endpoint of the study centered on the Objective Response Rate (ORR) according to RECIST 1.1 criteria. Secondary objectives included assessing Disease Control Rate (DCR), Duration of Response (DoR), Progression-Free Survival (PFS), Overall Survival (OS), safety, immunogenicity, as well as examining pharmacokinetics and biomarkers associated with efficacy.

As of 30th May 2023, 34 patients were successfully enrolled and received Fruquintinib Plus Sintilimab and the median follow-up duration was 16.4 months. As far as the patient pool is concerned, 6 patients (17.6%) were treatment naïve; 28 patients (82.4%) had received at least first-line treatment , including bevacizumab, for advanced disease. 

Out of the participants, 73.5% had undergone pelvic radiation therapy, and 70.6% had a PD-L1 status of CPS ≥1. For both treatment-naïve and previously treated patients whose tumors were evaluable, the confirmed Objective Response Rate (cORR) stood at 50.0% and 29.6%, with median Time to Response (TTR) recorded at 2.7 and 3.1 months. DCR was 100% for both groups. The mPFS was 10.3 months for treatment-naïve patients and 8.2 months for treated patients, while the 15-month OS rate was 83.3% and 70.0%, respectively.

In tumor evaluable treated patients stratified by CPS ≥1 vs <1, cORR was 41.2% vs. 12.5% and in treated patients, mPFS was 19.4 months vs. 5.2 months. 

All patients experienced treatment emergent adverse event (TEAEs), and the most common TEAEs included proteinuria (64.7%), hypothyroidism (61.8%), asthenia (44.1%), hyperthyroidism (44.1%), palmar-plantar erythrodysaesthesia syndrome (44.1%), anaemia (41.2%) and urinary tract infection (41.2%).

Conclusion

In conclusion, cervical cancer poses a significant health challenge for Chinese women, with a particularly poor prognosis for recurrent or metastatic cases. The standard first-line therapy involves platinum-containing chemotherapy and antiangiogenic therapy, but those who fail initial treatments face limited options and high unmet clinical needs.

The combination of fruquintinib, a highly selective VEGFR inhibitor, with sintilimab, an anti-PD-1 monoclonal antibody, has demonstrated promising antitumor activity in both pre-clinical and clinical studies. Importantly, fruquintinib plus sintilimab demonstrated a manageable safety profile, with proteinuria, hypothyroidism, and palmar-plantar erythrodysaesthesia syndrome being the most frequent treatment-related adverse events. These findings suggest that this combination therapy could represent a valuable treatment option for advanced cervical cancer patients, particularly those who have previously undergone systemic treatments, addressing the current unmet clinical needs in this challenging medical landscape.

Visit and Explore the Reference reports by DelveInsight for more in-depth analysis and key coverage - 

• Cervical Cancer Market Insight, Epidemiology, And Market Forecast
• Ovarian Cancer Market Insight, Epidemiology, And Market Forecast