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Dr Oberstein on Data for Pamrevlumab Plus Nab-Paclitaxel/Gemcitabine in PDAC

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Paul E. Oberstein, MD, discusses the efficacy and safety of pamrevlumab plus chemotherapy in first- and second-line PDAC.

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    “The primary finding the study is that there was no improvement in the investigational arm. The study was very exciting in that it enrolled very quickly [across] many sites and showed really positive outcomes in the standard of care arm and the ability to do a large, dynamic study like this, which hopefully will pave the way for more studies in pancreatic cancer.”

    Paul E. Oberstein, MD, director, Pancreatic Cancer Center, NYU Langone Health, discusses findings from the phase 2/3 Precision Promise trial (NCT04229004), a Bayesian platform trial that evaluated pamrevlumab plus nab-paclitaxel (Abraxane) and gemcitabine compared with nab-paclitaxel plus gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

    In this randomized, dynamic trial, Oberstein explains that investigators assessed the efficacy and safety of adding pamrevlumab, a connective tissue growth factor–targeted monoclonal antibody, to the chemotherapy backbone in first- and second-line metastatic PDAC.

    Results presented at the 2025 Gastrointestinal Cancers Symposium showed no improvement in progression-free survival (PFS) or overall survival (OS) with the addition of pamrevlumab. In the first-line cohort, median PFS was 5.3 months with concurrent nab-paclitaxel/gemcitabine (n = 23) and 5.9 months with pamrevlumab plus chemotherapy (n = 102; HR, 0.64; 95% CI, 0.36-1.14). Confirmed objective response rates (ORR) were 26.1% in the concurrent nab-paclitaxel/gemcitabine arm and 35.3% in the pamrevlumab combination arm. In the second-line setting, median PFS was 7.0 months with chemotherapy alone (n = 22) and 3.9 months with pamrevlumab plus nab-paclitaxel/gemcitabine (n = 111; HR, 1.35; 95% CI, 0.78-2.33). The ORRs were 4.5% and 9.0%, respectively.

    Oberstein notes that no new safety signals were observed with the addition of pamrevlumab, and the toxicity profile was consistent with the chemotherapy backbone.

    Oberstein highlights the efficiency and feasibility of the Bayesian platform design, which facilitated rapid enrollment and robust data generation. He emphasizes that although pamrevlumab did not demonstrate improved efficacy in this trial, the dynamic design of Precision Promise sets the stage for future studies in pancreatic cancer.

    Oberstein concludes that continued innovation in trial design and therapeutic approaches is critical to addressing the unmet needs of patients with metastatic PDAC. Future investigations may focus on identifying subgroups most likely to benefit from targeted therapies and optimizing combination strategies in this challengingdisease.