Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002)

Santin, Alessandro D.; Deng, Wei; Frumovitz, Michael; Buza, Natália; Bellone, Stefania; Huh, Warner K.; Khleif, Samir N.; Lankes, Heather A.; Ratner, Elena; O’Cearbhaill, Roisin E.; Jazaeri, Amir A.; Birrer, Michael J.

doi:10.1016/j.ygyno.2019.12.034

Cited by 119 publications

(98 citation statements)

References 17 publications

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“…The overall ORR among our 18 cervical cancer patients was 22% (4/18), which is comparable to the rate of 4-26% reported in previous studies as shown in Table 4. 8,[21][22][23] The ORRs for ovarian cancer (13%) and endometrial cancer (40%) in the present study were also similar to previously reported data: 10-33% for ovarian cancer 15,16,24,25 and 13-57% for endometrial cancer 14,24,26 as shown in Table 4. Prospective clinical trials and real-world experience studies differ on a couple of points.…”

Section: Discussionsupporting

confidence: 92%

Real-World Experience with Pembrolizumab Treatment in Patients with Heavily Treated Recurrent Gynecologic Malignancies

et al. 2020

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Purpose: We evaluated the efficacy and safety of pembrolizumab in patients with recurrent gynecologic cancers in real-world practice. Materials and Methods: We conducted a retrospective, single-institution study of patients with recurrent gynecologic malignancies treated with pembrolizumab. The primary endpoints were the objective response rate (ORR) and safety. Results: Thirty-one patients treated with pembrolizumab were included. The primary disease sites were the uterine cervix (n=18), ovaries (n=8), and uterine corpus (n=5). Fifteen of the 31 patients (48%) had an Eastern Cooperative Oncology Group performance status of ≥2. The median number of prior chemotherapy lines was 2 (range, 1-6), and 14 of 31 patients (45%) had received ≥ 3 prior lines of chemotherapy. The overall ORR was 22.6%: specifically, 22.3% (4 of 18 patients), 12.5% (1 of 8 patients), and 40% (2 of 5 patients) for cervical, ovarian, and endometrial cancers, respectively. During a median follow-up of 4.7 months (range, 0.2-35.3), the median time to response was 1.9 months (range, 1.4-5.7). The median duration of response was not reached (range, 8.8-not reached). The median progression-free survival was 2.5 months (95% confidence interval, 1.7-not reached). Adverse events occurred in 20 patients (64.5%), and only 3 (9.7%) were grade ≥3. There was one case of suspicious treatment-related mortality, apart from which most adverse events were manageable. Conclusion: In real-world practice, pembrolizumab was feasible and effective in heavily treated recurrent gynecologic cancer patients with poor performance status who may not be eligible for enrollment in clinical trials.

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Section: Discussionsupporting

confidence: 92%

Real-World Experience with Pembrolizumab Treatment in Patients with Heavily Treated Recurrent Gynecologic Malignancies

et al. 2020

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“…In CheckMate 358, a phase I/II study in patients with squamous histology only, the objective response rate was 26.3% (5/19) for cervical cancer with nivolumab [10]. Another study, with a patient population of 60% squamous histology, also reported a 4% response rate to nivolumab [11]. Although these observations are directionally consistent with the hypothesis that the clinical activity of PD-1 blockade in cervical cancer may partition with squamous histology, it is not possible to draw conclusions from small cross-study comparisons.…”

Section: Discussionmentioning

confidence: 99%

PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer

Rischin

Gil-Martín

González-Martín

et al. 2020

Gynecologic Oncology

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Objectives. To characterize the safety, tolerability, and anti-tumor activity of cemiplimab as monotherapy or in combination with hypofractionated radiation therapy (hfRT) in patients with recurrent or metastatic cervical cancer. To determine the association between histology and programmed death-ligand 1 (PD-L1) expression. Methods. In non-randomized phase I expansion cohorts, patients (squamous or non-squamous histology) received cemiplimab 3 mg/kg intravenously every 2 weeks for 48 weeks, either alone (monotherapy cohort) or with hfRT during week 2 (combination cohort). Due to insufficient tissue material, PD-L1 protein expression was evaluated in commercially purchased samples and mRNA expression levels were analyzed from The Cancer Genome Atlas (TCGA). Results. Twenty patients enrolled in both cohorts in total; 10 had squamous histology. The most common adverse events of any grade were diarrhea, fatigue, and hypokalemia, occurring in 35%, 25%, and 25%, respectively. Objective response rate was 10% in each cohort; responders had squamous histology. Duration of response was 11.2 months and 6.4 months for the responder in the monotherapy and combination cohort, respectively.

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“…Despite having favorable immune biology, patients with cervical cancer have seen modest activity with single-agent CPIs (164,165). The Phase II nonrandomized KEYNOTE-158 study evaluated pembrolizumab in 98 patients with recurrent or metastatic cervical cancer who had progressed on or were intolerant to at least one line of standard therapy and reported an ORR of 12% (166); all responses occurred in PD-L1-positive tumors.…”

Section: Cervical Cancermentioning

confidence: 99%

Augmenting Anticancer Immunity Through Combined Targeting of Angiogenic and PD-1/PD-L1 Pathways: Challenges and Opportunities

Hack¹,

Zhu

Wang³

2020

Front. Immunol.

182

132

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Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002)

Cited by 119 publications

References 17 publications

Real-World Experience with Pembrolizumab Treatment in Patients with Heavily Treated Recurrent Gynecologic Malignancies

Real-World Experience with Pembrolizumab Treatment in Patients with Heavily Treated Recurrent Gynecologic Malignancies

PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer

Augmenting Anticancer Immunity Through Combined Targeting of Angiogenic and PD-1/PD-L1 Pathways: Challenges and Opportunities

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