Opdivo for cervical cancer – pro
Nivolumab (Opdivo) demonstrated clinical activity in women with recurrent/metastatic cervical cancer, and was active to a lesser extent in vaginal and vulvar cancers, according to phase I/II results from CheckMate-358. esearchers enrolled 24 patients into the gynecologic arm of the CheckMate-358 trial from October 2015 to February 2016. Nineteen patients (79.2%) had cervical cancer and 5 (20.8%) had vaginal or vulvar cancer. Eligible patients had an ECOG performance score of 0 to 1 and ≤2 prior systemic therapies for relapsed/metastatic disease.
Fourteen patients (58.3%) were positive for HPV. HPV status was unknown for the 10 remaining patients (41.7%). All patients were treated with 240 mg of nivolumab every 2 weeks until progression or unacceptable toxicity.
While the overall DCR was 70.8%, nivolumab induced stronger responses in women with cervical cancer. At the July 2016 data cutoff, there was 1 complete response (CR) and 4 partial responses (PR), all among patients with cervical cancer (ORR = 26.3%). The best response among patients with vulvar or vaginal cancer was stable disease (80%).
Alejandra Fuentes, MD, and Agustin A. Garcia, MD, Advancements in Cervical Cancer Prevention and Management of Persistent, Recurrent, and Metastatic Disease: 2016 Update. AJHO. 2
Hollegecque A, Meyer T, Moore KN, et al. An open-label, multicohort, phase I/II study of nivolumab in patients with virus-associated tumors (CheckMate 358): Efficacy and safety in recurrent or metastatic (R/M) cervical, vaginal, and vulvar cancers. J Clin Oncol 35, 2017 (suppl; abstr 5504).
NCCN, Cervical 2018