On September 4, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported data will be released at ESMO (Free ESMO Whitepaper) Congress 2022 in Paris, France about the efficacy and safety of PNT2002 in the lead-in cohort of the SPLASH trial (Press release, Point Biopharma, SEP 4, 2022, View Source [SID1234618993]). An abstract is now available on the ESMO (Free ESMO Whitepaper) congress website at View Source, and an e-poster which contains updated data will be published and presented on Sunday, September 11th.
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The poster is titled "Efficacy and Safety of 177Lu-PNT2002 Prostate-Specific Membrane Antigen (PSMA) Therapy in Metastatic Castration Resistant Prostate Cancer (mCRPC): Initial Results from SPLASH" (e-Poster #1400P), and is scheduled for presentation on Sunday, September 11 from 9:00-17:00 CEST (Paris) by Dr. Aaron R. Hansen, staff medical oncologist of Princess Alexandra Hospital and an Associate Professor of Medicine at the University of Toronto.
In advance of the publication of the abstract, the Company recently hosted a 45-minute educational webinar entitled "Understanding the PNT2002 SPLASH Trial Control Arm". A replay of the webinar is available online at View Source
About the SPLASH Trial
The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.