US-based Lantheus and POINT Biopharma have announced positive topline data from the Phase III trial investigating prostate cancer therapy 177Lu-PNT2002, as Eli Lilly extends its tender offer deadline. 

The candidate is a radioligand therapy (RLT) targeting the prostate-specific membrane antigen (PSMA) in patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed on androgen receptor pathway inhibitors (ARPI). 

The study demonstrated a statistically significant median radiographic progression-free survival (rPFS) of 9.5 months with 177Lu-PNT2002 compared to six months with ARPI, indicating a 29% reduction in the risk of radiographic progression or death. 

The multicentre, randomised, open-label SPLASH trial (NCT04647526) enrolled 412 PSMA-expressing patients across the US, Canada, Europe, and the UK, with 84.6% of control arm patients crossing over to receive 177-Lu-PNT2002 upon disease progression. 

Interim overall survival (OS) results are pending, with additional data expected in 2024 before a potential new drug application (NDA) submission.  

In the announcement accompanying the results, POINT’s co-founder and chief medical officer Neil Fleshner said: “The success of 177Lu-PNT2002 in this trial demonstrates the value of treating patients with radioligand therapy at this stage of the disease continuum. 

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By GlobalData

“With only four treatment administrations over 32 weeks, this regimen provides reduced treatment intensity compared to the control arm, while also delaying disease progression with lower toxicity.” 

On the same day as the data announcement, Eli Lilly extended its tender offer expiration date after opposition at POINT, evidenced by complaint letters from shareholders and lawsuits filed against POINT and its board members. Lilly released a statement extending the tender offer to 22 December 2023.  

The company first announced the potential acquisition in an all-in cash deal value of nearly $1.4bn in October.  

POINT has several other radioligand therapies in its pipeline for the treatment of neuroendocrine tumours, solid tumours expressing FAP, and prostate cancer.  

According to GlobalData’s Pharma Intelligence Center, 177Lu-PNT2002 is forecasted to generate $1.2bn in sales in 2029.  

GlobalData is the parent company of Clinical Trials Arena.