The designation is for patients with mCRPC who have progressed on an androgen receptor pathway inhibitor and are not eligible for or decline to receive chemotherapy.
The FDA has granted its Fast Track designation to the PSMA-targeted therapy 177Lu-PNT2002 for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).1
The novel agent is currently being explored in the phase 3 SPLASH trial (NCT04647526). The study is accruing patients with PSMA-expressing mCRPC who have experienced disease progression on an androgen receptor pathway inhibitor in either the castration-sensitive or CRPC setting, and who are not eligible for or decline chemotherapy.
“Fast track designation by the FDA is an important milestone and recognizes the potential for 177Lu-PNT2002 to address the significant unmet need for mCRPC patients,” Jean-Claude Provost, MD, chief medical officer at Lantheus, which co-develops 177Lu-PNT2002 with POINT Biopharma, stated in a press release.
“We are encouraged by the FDA’s decision as it reflects the need for FDA approved and widely available treatments for these patients. This designation will allow us to work closely with the FDA, along with our partner POINT, to quickly advance 177Lu-PNT2002, with the potential to make a meaningful difference for patients who require new treatment options,” added Provost.
To enroll in the open-label SPLASH trial, patients must have an ECOG performance status of 0 to 1 and a positive PSMA-PET scan on a validated test, such as 68Ga-PSMA-11 or 18F-DCFPyL (piflufolastat F 18; Pylarify). Lantheus and POINT announced in January 2023 that patient enrollment was complete for the randomization component of the trial. At the time, there were more than 390 patients enrolled and randomized in the trial at locations in 55 sites across North America, Europe, and the United Kingdom.
The randomization phase was launched after successful completion of the open-label dosimetry and safety run-in phase, in which all prespecified safety and efficacy criteria were met. There were 27 patients who participated in this phase.
In the randomization phase, patients are assigned in a 2:1 ratio to either 177Lu-PNT2002 (arm A) or abiraterone or enzalutamide (arm B).2 Crossover from the control arm to receive 177Lu-PNT2002 will be allowed at radiographic progression among patients who meet the study protocol eligibility criteria. The primary end point of the study is radiographic progression-free survival. Other key end points include overall response rate, overall survival, biochemical PFS, duration of response, pharmacokinetics, and safety.
Based on a strategic collaboration that POINT entered into with Lantheus Holdings, POINT is funding the SPLASH trial and Lantheus, in collaboration with POINT, will be responsible for filing a New Drug Application with the FDA should it be warranted by the SPLASH results.
“The FDA Fast Track designation for 177Lu-PNT2002 underscores its potential to address a serious unmet need and serve as a meaningful therapeutic option for patients with mCRPC,” Neil Fleshner, MD, chief medical officer of POINT, stated in a press release. “We are seeing that radioligand therapy is quickly becoming another pillar of cancer treatment, and, with our continued focus on supply chain excellence, we believe that we are very well positioned to meet market demands post approval. We will continue to work closely with our partner Lantheus and with the FDA to bring 177Lu-PNT2002 to patients as quickly as possible.”
1. Lantheus and POINT Biopharma Announce FDA Grants Fast Track Designation for 177Lu-PNT2002 for the Treatment of Metastatic Castration Resistant Prostate Cancer. Published online April 24, 2023. https://yhoo.it/41WPgWm
2. POINT Biopharma Completes Randomization in PNT2002’s Phase 3 SPLASH Trial. Published online and accessed January 12, 2023. https://yhoo.it/3ZxaHNx