Nivolumab shows promise in recurrent or metastatic cervical, vaginal/vulvar cancers
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Nivolumab showed promising efficacy among women with recurrent or metastatic cervical, vaginal or vulvar cancers, according to results from the single-arm phase 1/phase 2 CheckMate 358 trial published in Journal of Clinical Oncology.
“We know that most cervical cancers are virally induced ... so this is a treatment, from a rational standpoint, that makes sense,” R. Wendel Naumann, MD, professor and associate director of gynecologic oncology at Levine Cancer Institute at Atrium Health, told HemOnc Today. “What we don’t know yet is if this can be combined with chemotherapy or radiation to make these treatments more effective.”
The ongoing CheckMate 358 trial was designed to evaluate nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 immune checkpoint inhibitor — for a variety of virus-associated tumors.
The gynecologic cancer cohort included 24 women with squamous cell carcinoma, including 19 with cervical carcinoma (median age, 51 years; range, 28-75) and five with vaginal/vulvar carcinoma (median age, 59 years; range, 40-78). Women known to have HPV-negative tumors were excluded from this study; however, researchers enrolled women with unknown HPV status.
Most of the women (cervical, 78.9%; vaginal/vulvar, 80%) had received systemic therapy for metastatic disease.
Women received nivolumab dosed at 240 mg every 2 weeks. Median duration of nivolumab treatment was 5.6 months (range, 0.5-31.4+) in the cervical cancer group and 6.7 months (range, 2.1-7.5) in the vaginal/vulvar cancer group.
Objective response rates served as the primary endpoint. Duration of response, PFS and OS served as secondary endpoints.
Results showed ORRs of 26.3% (95% CI, 9.1-51.2) for women with cervical cancer and 20% (95% CI, 0.5-71.6) for women with vaginal/vulvar cancer.
After median follow-up of 19.2 months, median duration of response was not reached (range, 23.3-29.5+) among the five women with cervical cancer who responded to treatment. The one woman in the vaginal/vulvar cancer group who responded to treatment remained in response for 5 months.
Median PFS was 5.1 months (95% CI, 1.9-9.1) and median OS was 21.9 months (95% CI, 15.1-not reached) in the cervical cancer group.
Researchers did not calculate median PFS and OS in the vaginal/vulvar cancer group because of its small size; however, 40% of women in that group remained progression-free at 6 months, 40% (95% CI, 5.2-75.3) were alive at 12 months, and 20% (95% CI, 0.8-58.2) were alive at 18 months.
Most women in the cervical cancer group (63.2%) and all five women in the vaginal/vulvar cancer group experienced any-grade treatment-related adverse events, including diarrhea, fatigue and decreased appetite. No treatment-related deaths occurred during the study.
The small number of women evaluated, as well as a lack of independent radiologic reviews of tumor responses, served as the study’s primary limitations.
“We are very excited about the response rate, which was actually higher in this population than what we have seen with pembrolizumab [Keytruda, Merck],” Naumann said. “These are really exciting agents.”
The researchers will present results of combination-therapy arms from CheckMate 358 at this year’s European Society for Medical Oncology Congress, which will be held Sept. 27-Oct. 1 in Barcelona. – by John DeRosier
For more information:
R. Wendel Naumann, MD, can be reached at Levine Cancer Institute at Atrium Health, 1021 Morehead Medical Drive, Charlotte, NC 28204; email: wendel.naumann@atriumhealth.org.
Disclosures: Naumann reports consultant/advisory and speakers bureau roles with Genentech; consultant/advisory roles with AstraZeneca, Clovis Oncology, Ethicon, Merck Sharp & Dohme, Sutro Biopharma, Tempus and Tesaro/GlaxoSmithKline; and research funding from Bristol-Myers Squibb, OncoMed and Sutro Biopharma. Please see the study for all other authors’ relevant financial disclosures.
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