NIvolumab and ipilupimab for refractory cervical cancer – pro
Investigators in the phase I/II CheckMate-358 trial sought to provide clinical evidence showing the value of nivolumab (Opdivo) alone or in combination with ipilimumab (Yervoy) in patients with recurrent or metastatic cervical, vaginal, and vulvar cancer.
In the nivolumab-alone cohort, 24 patients received 10 mg of intravenous nivolumab every 2 weeks for a maximum of 2 years, or until disease progression or unacceptable toxicity. The median duration of treatment was 5.6 months in the cervical cancer cohort and 6.7 months in the vaginal/vulvar cancer cohort.
In the cervical cancer cohort (n = 19), 37.5% of patients had PD-L1–negative tumors and 42% had undergone ≥2 lines of systemic therapy.
The ORR was 26.3% (95% CI, 9.1-51.2) in the cervical cancer arm and 20.0% (95% CI, 0.5-71.6) in the vaginal/vulvar cancer arm (n = 5).3 At a median follow-up of 19.2 months, the median duration of response (DOR) was not reached in the cervical arm and was 5.0 months in the vaginal/vulvar cancer arm.
The median PFS in the cervical cancer group was 5.1 months (95% CI, 1.9-9.1) with a median OS of 21.9 months (95% CI, 15.1-not reached). Because of the small number of patients in the vaginal/vulvar cancer cohort, the median PFS and OS were not calculated.
THisisi a retrospective information and requires confirmation by larger prospective studies before being considered no E/I.
Chung HC, Ros W, Delord JP, et al. Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: results from the phase II KEYNOTE-158 study. J Clin Oncol. 2019;37(17):1470-1478. doi: 10.1200/JCO.18.01265.
Naumann RW, Hollebecque A, Meyer T, et al. Safety and efficacy of nivolumab monotherapy in recurrent or metastatic cervical, vaginal, or vulvar carcinoma: results from the phase I/II CheckMate 358 trial. J Clin Oncol. 2019;37(31):2825-2834. doi: 10.1200/JCO.19.00739.
Naumann RW, Oaknin A, Meyer T, et al. Efficacy and safety of nivolumab + ipilimumab in patients with recurrent/metastatic cervical cancer: results from CheckMate 358. Ann Oncol. 2019;30(suppl_5):mdz394.059. doi: 10.1093/annonc/mdz394.059.