Don Tracy, Associate Editor

Partnership also includes an agreement for Arvinas to sell its preclinical AR-V7 program to Novartis.
Novartis and Arvinas announced that they have agreed to terms on a collaboration to develop and commercialize ARV-766, Arvinas’ advanced Protac androgen receptor degrader designed for prostate cancer treatment. Per terms of the deal, Novartis will focus on worldwide clinical development, commercialization, and will obtain all associated rights for ARV-766 and the AR-V7 program. In turn, Arvinas will receive an upfront payment of $150 million, with the ability to receive up to $1.01 billion based on developmental, regulatory, and commercial milestones, plus royalties on sales of ARV-766.
Completion of the deal depends on when regulatory approvals are met, which requires acquiescence with the Hart-Scott-Rodino Act.1
“We are thrilled to partner with an organization that shares our dedication to delivering transformative medicines to patients with significant unmet need,” said John Houston, PhD, chairperson, president, CEO, Arvinas, in a press release. “We believe the expertise and scale of Novartis will broaden the development of ARV-766 and its potential to be a first- and best-in-class treatment for patients with prostate cancer. This strategic transaction also further validates our innovative PROTAC protein degrader platform and its potential to deliver new treatments.”
Last June, Arvinas revealed promising results from its Phase I/II dose escalation and expansion trial of ARV-766 in men with metastatic castration-resistant prostate cancer (mCRPC). According to the company, the trial displayed promising activity in a heavily pre-treated, post-novel hormonal agent (NHA), all-comers patient population.2
“Tumor resistance mechanisms such as AR LBD mutations are increasing with earlier use of NHAs, leaving limited treatment options for men with prostate cancer in the post-NHA setting,” said Houston, in a press release. “It’s very exciting to see ARV-766 show signs of efficacy in these late-line patients, including in patients with L702H mutations. Our AR franchise now includes data showing two active clinical compounds with good tolerability profiles and the potential to address high unmet need in castrate-resistant and castrate-sensitive prostate cancer.”
Forty-two percent of patients with AR ligand-binding domain mutations reached a 50% reduction in prostate-specific antigen (PSA50). Additionally, 60% of patients who carried the L702H mutation achieved PSA50. Further details of these findings were discussed at the Jefferies Healthcare Conference on June 8, 2023.2
“The patients in this trial received extensive prior therapy for mCRPC and had limited alternative treatment options,” said Ron Peck, MD, chief medical officer, Arvinas, in the press release. “These data increase our confidence in our ability to bring innovative treatment options to a patient population with significant unmet need. We are excited by the progress in our AR franchise and the potential for bavdegalutamide and ARV-766 to address settings across the continuum of prostate cancer and potentially other AR-driven cancers.”