Final results of a phase II trial of prolgolimab with platinum-based therapy and bevacizumab in patients with advanced cervical cancer.

Authors

null

Sergey Fogt

Biocad, Saint-Petersburg, Russian Federation

Sergey Fogt , Timur Andabekov , Yana Shamsutdinova , Mikhail Dvorkin , Elena Artamonova , Valerii Chistyakov , Ruslan Zukov , Vladimir Moiseenko , Marina Nechaeva , Svetlana Odintsova , Natalia Fadeeva , Nikolai Kislov , Denis Tantsyrev , Sergei Tjulandin , Eugeniy Fomin , Iuliia Linkova , Arina Zinkina-Orikhan , Mariia Shustova , Lyudmila Zhukova

Organizations

Biocad, Saint-Petersburg, Russian Federation, AV Medical Group, Saint-Petersburg, Russian Federation, Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan, Kazan, Russian Federation, Omsk Region Clinical Oncologic Dispensary, Omsk, Russian Federation, Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation, Moscow, Russian Federation, Novaya klinika, Pyatigorsk, Russian Federation, V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk, Russian Federation, Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology), Saint-Petersburg, Russian Federation, Arkhangelsk Regional Clinical Oncologic Dispensary, Arkhangelsk, Russian Federation, Modern Medical Technologies Clinic, Saint-Petersburg, Russian Federation, Chelyabinsk Regional Center of Oncology and Nuclear Medicine, Chelyabinsk, Russian Federation, Yaroslavl Region Clinical Oncological Hospital, Yaroslavl, Russian Federation, Altai Regional Oncology Center, Barnaul, Russian Federation, N.N. Blokhin Russian Cancer Research Center, Moscow, G Moskva, Russian Federation, Murmansk Regional Clinical Hospital n.a. P.A. Bayadin, Murmansk, Russian Federation, BIOCAD, Moscow, Russian Federation, Chemotherapy and Bone Marrow Transplant Unit 1, Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation, Moscow Clinical Scientific Center named after A.S. Loginov, Moscow, Russian Federation

Research Funding

Pharmaceutical/Biotech Company
BIOCAD

Background: Here we present the final results of single-arm phase II CAESURA (NCT03912402) study of prolgolimab (anti-PD-1 antibody) with platinum doublet and bevacizumab in subjects with advanced cervical cancer (CC). Methods: 58 patients (pts) with metastatic or recurrent/persistent CC with measurable disease received prolgolimab (3 mg/kg) Q3W together with paclitaxel, platinum drug (cis- or carboplatin) and bevacizumab for 6 cycles and then therapy with prolgolimab and bevacizumab until disease progression or toxicity. Objective response rate (ORR) was assessed by central radiology review per RECIST 1.1 (primary endpoint) and iRECIST criteria. CT scans were performed after 9 and 18 weeks of treatment and in case of suspicion on disease progression. Results: Distant metastases at screening had 42 pts, 16 had recurrent or persistent CC. The median age of pts was 48 [38; 58] years old. Squamous cell carcinoma was diagnosed in 50 of 58 subjects. PD-L1 CPS ≥ 1 (22C3) was found in 45 pts, CPS < 1 in 6 cases. ORR per RECIST 1.1 was 63.8% (37 of 58 pts) and included 2 complete, 35 partial responses. ORR per iRECIST was 70.7% (41 of 58 pts) with 2 complete and 39 partial responses. At the cut-off date (12 months) PFS (secondary endpoint) per RECIST 1.1 criteria counted 8.5 (95% CI 5.7; 10.9) months, per iRECIST criteria it reached 13.1 (95% CI 8.1; 13.6) months. Median overall survival was not reached. Any grade adverse events (AEs) occurred in 98% (57/58) of pts, of them in 69% (40/58) they were related to study treatment, including 12 cases of severe events (gr. 3 or higher). Immune-related AEs (irAEs) occurred in 38% (22/58) of pts. The most common irAEs were gr. 1–2 endocrine disorders (26%), including thyroid disorders and one case of gr. 2 adrenal insufficiency. Other important irAEs included 2 cases of enterocolitis (gr. 3 and 4), 1 case of dermatitis (gr. 3), several cases of gr. 2–3 transaminase elevation (9%). In 15 pts at least one component of study treatment was discontinued due to AE, of them 4 events were related to study treatment (including immune-related enterocolitis and adrenal insufficiency). Conclusions: Prolgolimab in combination with chemotherapy and bevacizumab demonstrated promising efficacy, known and acceptable safety profile in pts with advanced CC. Phase III placebo-controlled trial evaluating prolgolimab with chemotherapy and bevacizumab (NCT03912415) as first-line therapy option in subjects with CC is ongoing. Clinical trial information: NCT03912402.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Cervical Cancer

Clinical Trial Registration Number

NCT03912402

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 5536)

DOI

10.1200/JCO.2023.41.16_suppl.5536

Abstract #

5536

Poster Bd #

231

Abstract Disclosures