359 | UPDATED RESULTS FROM KEYNOTE‐B68: PEMBROLIZUMAB EVERY 6 WEEKS IN PARTICIPANTS WITH RELAPSED OR REFRACTORY CLASSIC HODGKIN LYMPHOMA OR PRIMARY MEDIASTINAL B‐CELL LYMPHOMA
Makaleler > Tam Makale · 2025
Yazarlar: A. McDonald, E. Verburgh, M. Gotti, A. Pinto, J. Zaucha, V. Ivanov, V. Melnichenko, H. Mocikova, M. Ozcan, C. Patti, J. Farias, l. Goncalves, O. Kuchkova, J. Mayer, Güray SAYDAM, S. Tomassetti, K. Pathiraja, K. Ryland, R. Yusuf, W. Jurczak
Hematological Oncology, Uluslararası, Wos, 2025, cilt 43
Özet
Introduction: Pembrolizumab (pembro) administered at 400 mg every 6 weeks (Q6W) is approved for use in adults based on data from solid tumors. KEYNOTE-B68 (NCT04875195) was a phase 2 study designed to evaluate pembro Q6W in participants (pts) with relapsed or refractory (R/R) classic Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL). In a prior analysis (median follow-up, 16 mo), the objective response rate (ORR) was 67% for pts with cHL and 50% for PMBCL. An updated analysis is presented. Methods: Eligible pts were aged ≥ 18 y and had PD-1 inhibitor–naive cHL or PMBCL. Pts with cHL were required to have R/R disease after ≥ 1 prior line of therapy; pts with PMBCL were required to have R/R disease after ≥ 2 prior lines of therapy (including rituximab) and be ineligible for or R/R to autologous stem cell transplant (SCT). All pts were treated with pembro 400 mg IV Q6W for ≤ 18 cycles. The primary end point was ORR per Lugano criteria by investigator review. Secondary end points were duration of response (DOR) and safety. Progression-free survival (PFS) and overall survival (OS) were exploratory. Results: Of 66 pts enrolled, 60 (91%) had cHL and 6 (9%) had PMBCL. At the data cutoff (May 13, 2024), 13 pts (20%) had completed treatment and 53 (80%) had discontinued (primarily due to progressive disease [PD], n = 39). Median study follow-up was 27.7 mo for cHL (range, 19.8–34.7) and 29.4 mo for PMBCL (range, 23.9–34.2). The ORR was 67% (95% CI: 53–78) for cHL (complete response [CR], n = 21; partial response [PR], n = 19) and 50% (95% CI: 12–88) for PMBCL (CR, n = 2; PR, n = 1). Median DOR was 15.2 mo (range, 0.0+ to 29.8+) for cHL and 9.7 mo (range, 2.6–9.7) for PMBCL. Median PFS was 8.3 mo (95% CI: 5.6–13.8) for cHL and 4.1 mo (95% CI: 0.1-NR) for PMBCL; 12-mo PFS rates were 39% and 33%. Median OS was not reached (NR; 95% CI: NR-NR) for cHL and 24.8 mo (95% CI: 0.1-NR) for PMBCL; 24-mo OS rates were 88% and 67%. Twenty-two pts with cHL underwent SCT after stopping pembro; 12 had CR and 2 were not evaluable (NE) after autologous SCT, and 7 had CR and 1 was NE after allogenic SCT. Four pts with PMBCL underwent SCT after stopping pembro; 1 had CR, 1 had PR, 1 had PD after autologous SCT, and 1 had CR after allogenic SCT. Any-grade treatment-related AEs were reported in 26 pts (43%) with cHL and 2 (33%) with PMBCL (grade 3 or 4: n = 3 [5%] and n = 1 [17%]). No treatment-related deaths occurred. Immune-mediated AEs and infusion reactions were reported in 14 pts (23%) with cHL and 1 (17%) with PMBCL (grade 3 or 4: n = 2 [3%] and n = 0). No deaths due to immune-mediated AEs or infusion reactions occurred. Conclusions: With 12 mo of additional median follow-up, pembro 400 mg Q6W continued to demonstrate durable antitumor activity in R/R cHL or R/R PMBCL. No new safety signals were reported. These results support the use of pembro 400 mg Q6W in pts with hematologic cancers. Research funding declaration: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA Encore Abstract: ASCO 2025; EHA 2025; Regional or national meetings with up to 1000 attendees Keywords: aggressive B-cell non-Hodgkin lymphoma; immunotherapy; Hodgkin lymphoma Potential sources of conflict of interest: A. McDonald Employment or leadership position: Alberts Cellular Therapy Consultant or advisory role: Roche, Abbvie, Janssen Stock ownership: Netcare Pty(Ltd), Netcare Pretoria East Hospital Educational grants: Abbvie, Janssen, Amgen Other remuneration: Speaker's Bureau: Astra-Zeneca, Takeda, Janssen; Research Funding: Abbvie, Janssen, Merck, Novartis, Astra-Zeneca E. Verburgh Other remuneration: Research Funding: MSD A. Pinto Consultant or advisory role: Roche, Beigene, SOBI, AbbVie, Incyte, Take Stock ownership: Autolus Therapeutics, IGM BIOscience Honoraria: Roche, Incyte, SOBI, ELy-LILLY, Beigene, MSD, BMS Educational grants: Roche J. Zaucha Consultant or advisory role: Roche, Takeda, Abbvie Educational grants: Roche, Takeda Other remuneration: Research Funding: BMS V. Ivanov Other remuneration: Speaker's Bureau: Pfizer, Novartis, Biocad, Rosh, Abbvie, AlPharma, Sotex; Expert Testimony: Biocad; Other: Clinical trials for Ascentage, MSD, Abbvie, Biocad, H. Mocikova Consultant or advisory role: Abbvie, J&J, Eli-Lilly, Roche, AstraZeneca, Takeda Educational grants: Abbvie, J&J, Takeda, AstraZeneca Other remuneration: Speaker Bureau: Takeda, Abbvie, J&J, Ei-Lilly, Roche M. Ozcan Educational grants: Abbvie, Sandoz, MSD, Turgut Medicine Other remuneration: Research: Abbvie, Bayer, Janssen, Acerta, MSD, Roche, Takeda, Pfizer, PSI, Lilly, ADC Therapotic, IQVIA, Beigene J. Mayer Other remuneration: Research Funding: MSD S. Tomassetti Consultant or advisory role: Novartis Stock ownership: Proctor & Gamble, Eli Lilly Other remuneration: Research Grant: Novartis, Merck, Principia, Genetech, Sanofi, Rigel, Seagene, Pfizer, Kartos K. Pathiraja Employment or leadership position: Merck K. Ryland Employment or leadership position: Merck Stock ownership: Merck R. Yusuf Employment or leadership position: Merck Stock ownership: Merck W. Jurczak Consultant or advisory role: Abbvie/Genentech, AstraZeneca, BejGene, Janssen-Cilag, Lilly, Takeda Other remuneration: Research: Abbvie/Genentech, AstraZeneca, BejGene, Janssen-Cilag, Lilly, Merck, MSD, Roche, Takeda