On August 18, 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 the company will be publishing an abstract at ESMO (Free ESMO Whitepaper) Congress 2022, which takes place in Paris, France on September 9-13, 2022 (Press release, Point Biopharma, AUG 18, 2022, View Source [SID1234618513]).
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The abstract 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" (Abstract #1400P) and focuses on efficacy and safety data from the 27-patient safety and dosimetry lead-in cohort for the Company’s phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
In advance of the publication of the abstract, the Company also hosted a 45-minute educational webinar entitled "Understanding the PNT2002 SPLASH Trial Control Arm", which provided information regarding:
The SPLASH trial design (including lead-in phase) and rationale for hormone switches
Control arm benchmarks, and why PROfound1 & IMbassador2502 were selected as the SPLASH trial benchmarks
Current treatment patterns, including sequencing considerations, in real-world clinical settings for mCRPC patients
The webinar featured presentations from Dr. Oliver Sartor, MD, Professor of Medicine, Medical Director, Tulane Cancer Center, University of Tulane School of Medicine, and Dr. Kim Chi, MD, Vice President and Chief Medical Officer, British Columbia Cancer Agency.
Drs. Sartor and Chi were joined by the Company’s executive leadership team including Dr. Sherin Al-Safadi, VP Medical Affairs.
A replay of the webinar is now available online at View Source
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.