Novartis bets big on Arvinas Arvinas' prostate cancer degrader in $1B+ deal

2024-04-11

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蛋白降解靶向嵌合体临床1期引进/卖出

Novartis is boosting its prostate cancer pipeline through a deal potentially worth over $1 billion to secure global rights to Arvinas Arvinas' ARV-766, an oral androgen receptor (AR) protein degrader poised to move into Phase III testing.

The Swiss pharma is paying $150 million upfront, with potential milestones totaling $1.01 billion tied to ARV-766's development, regulatory, and commercial progress. Novartis, which recently said it plans to expand the label for its prostate cancer radioligand treatment Pluvicto, will take over all future R&D and commercialisation responsibilities for ARV-766, a product of Arvinas' PROTAC protein degrader platform.

The transaction also includes an agreement for the sale of Arvinas Arvinas' preclinical AR-V7 programme in metastatic castration-resistant prostate cancer (mCRPC). AR-V7 is a splice variant of the androgen receptor.

The deal allows Novartis to tap into the novel targeting mechanism of PROTACs, which induce degradation of disease-causing proteins rather than simply inhibiting them. According to Arvinas, ARV-766 has demonstrated activity in preclinical models of wild-type AR tumours as well as those with AR mutations or amplification, both of which can drive treatment resistance to current therapies.

"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," said John Houston, CEO of Arvinas, in a company release Thursday.

Promising interim data

Late last year, Arvinas reported interim Phase I/II data for ARV-766 at the European Society for Medical Oncology (ESMO) congress. In mCRPC patients harbouring any AR ligand-binding domain mutation, ARV-766 demonstrated a PSA50 response of 41%, with the rate rising to 50% in those with the L702H mutation.

"The increasing prevalence of the L702H mutation means that more patients could potentially benefit from the broader efficacy profile offered with ARV-766," Daniel Petrylak, an investigator working on the ARV-766 trials, said following last year's ESMO readout.

ARV-766 also had a better tolerability profile compared to the company's earlier PROTAC degrader bavdegalutamide, with lower rates of fatigue, nausea, vomiting and diarrhoea. That combined with the efficacy data could position it as a "superior" PROTAC AR degrader versus bavdegalutamide for both mCRPC and metastatic castration-sensitive prostate cancer (mCSPC), according to the company.

In a recent note to clients, BMO analysts said progression-free survival (PFS) data for ARV-766 is on track to readout in mid-2024, and that Arvinas plans this quarter to provide regulators with 100mg and 300mg dose data for candidate along with design plans for the Phase III programme.

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