POINT Biopharma shareholders get long-awaited radioligand therapy data
19 Dec 2023
Phase 3Clinical ResultAcquisition
POINT Biopharma unveiled the Phase III data that its shareholders have been waiting for, with the SPLASH study of 177Lu-PNT2002 in patients with metastatic castration-resistant prostate cancer (mCRPC) hitting its primary endpoint. However, the PSMA-targeted radioligand therapy did not seem to perform better than Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) – something that investors had been hoping for.
Eli Lilly reached a deal back in October to buy POINT for $12.50 per share in cash, or approximately $1.4 billion, representing a premium of 87%. Despite the agreement having the backing of POINT’s board, the majority of shareholders have chosen to hold onto their stock, with only around 22.81% of outstanding shares validly tendered into the offer as of December 15.
Investor hopes pinned to data
Instead, POINT’s stock price has steadily risen since Eli Lilly’s offer was announced, reaching just over $14 per share ahead of the SPLASH readout, with investors possibly hoping that positive results could lead to a higher offer or another buyout offer. Following the data release, shares in POINT fell back below Eli Lilly’s offer price, with the latter extending the closing of the tender to December 22.
The SPLASH trial enrolled 412 patients with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. Subjects were randomised to receive 177Lu-PNT2002 or either Johnson & Johnson’s Zytiga (abiraterone) or Astellas and Pfizer’s Xtandi (enzalutamide), with the study’s main goal being radiographic progression-free survival (rPFS).
Results below expectations
Top-line results showed that 177Lu-PNT2002 significantly reduced the risk of radiographic progression or death by 29% versus ARPI therapy, with rPFS in the two groups of 9.5 months and 6.0 months, respectively. POINT noted that while interim overall survival (OS) results are immature, the hazard ratio was 1.1. Ahead of the readout, Jefferies analysts suggested that the base-case scenario for 177Lu-PNT2002 in the SPLASH study would be rPFS of around 10 months to 11 months.
Earlier this year, Novartis reported that median rPFS for Pluvicto in the Phase III PSMAfore trial was 12 months, compared to 5.6 months for those on ARPI therapy. However, the study – which enrolled patients with PSMA-positive mCRPC after treatment with ARPI therapy – has so far failed to show a survival benefit, with Pluvicto associated with a hazard ratio of 0.8 for OS. Novartis has said that this may be "confounded" by the high crossover rate, as 84% of those who discontinued ARPI due to radiographic progression switched to Pluvicto.
POINT also highlighted a high crossover rate in SPLASH, with 84.6% of patients who experienced progressive disease in the control arm subsequently switching to treatment with 177Lu-PNT2002. “With only four treatment administrations over a 32-week period, this regimen provides reduced treatment intensity compared to the control arm,” remarked Neil Fleshner, POINT’s chief medical officer. The company, along with partner Lantheus, expect additional, follow-up data in 2024 prior to a potential marketing application to the FDA.
Novartis remains leader
Commenting on the SPLASH results, Stifel Nicolaus analysts said POINT’s therapy is no longer considered “as a too serious competitor” to Pluvicto, which they added “very much looks like first and best-in-class now.” Sales of Novartis’ product jumped 220% in the third quarter to $256 million, with Stifel Nicolaus estimating revenue of $4.5 billion in 2028.
While 177Lu-PNT2002 is POINT’s most advanced development candidate, Eli Lilly is keen to acquire the company to give it a starting point for entering the radioligand field. Speaking to FirstWord earlier this year, Jacob Van Naarden, president of Eli Lilly's oncology unit Loxo@Lilly, said it was important to acquire a company that has “already built a lot of great capabilities,” in order to “jumpstart” its efforts in the space, adding “it was absolutely not a capability that I thought we could build on our own.”
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