Novartis, BeiGene end $300M+ TIGIT partnership, citing data, competition and money

Novartis and BeiGene have mutually agreed to axe their collaboration on a Phase III TIGIT inhibitor, marking another derailment in a field once thought to be the next immunotherapy breakthrough.

Novartis doled out $300 million to kick off their partnership for ociperlimab in 2021, and was willing to pay up to $700 million more if it had decided to pick up the development and commercialization rights in multiple countries before the end of this year.

The rights will fall squarely on BeiGene, which will continue one Phase III and end the other. The decision went into immediate effect on Monday, BeiGene said in an SEC filing.

Spokespeople for BeiGene and Novartis sent the same statement in response to Endpoints News’ inquiry about the termination decision: “We assessed the totality of the data, benefit/risk, competitive space, timing, development programs, and future investments to make this decision.”

With recent troubles at Roche and Gilead/Arcus, this wasn’t a surprise, TD Cowen analyst Yaron Werber wrote in a Tuesday morning note.

The TIGIT field reached its nadir last year with back-to-back failures for Roche’s late-stage program and ran into further speed bumps as Gilead/Arcus’ Phase II update at ASCO was more mixed than an earlier readout.

Vas Narasimhan

After the Roche failures, Novartis CEO Vas Narasimhan said the dataset from its Basel neighbor “doesn’t change anything for us.”

“We’ll continue to wait and watch as the field evolves and then make an appropriate decision,” he said in a July 2022 earnings call. “Everyone would like to understand where is the appropriate use of this medicine and in which PD-1 subgroup, all comers, and if there is a place, which place would it actually be.”

BeiGene will continue enrolling in the late-stage AdvanTIG-302 trial of ociperlimab in combination with its own anti-PD-1 antibody, tislelizumab, which has been through its own regulatory hurdles. That study is testing the combo as a first-line treatment for patients with certain non-small cell lung cancers and is slated to collect final primary data in January 2025.

It’s ending the other study, which is testing the combo versus AstraZeneca’s Imfinzi in patients with stage 3 unresectable NSCLC. The drugmaker cited “the changing treatment paradigm” for culling the AdvanTIG-301 trial.

It also means Novartis will no longer proceed with a Phase II in first-line triple negative breast cancer.

The Swiss Big Pharma hinted at its lowered ambitions for the program when it didn’t start a new Phase III for ociperlimab in solid tumors last year.

“BeiGene management has also previously noted that their expectations for ociperlimab were modest, and that the program was primarily a way to capture potential upside with minimal financial risk, given that Novartis had already paid $300M upfront as part of the original collaboration agreement,” Werber wrote. “Thus, our thesis for BeiGene remains unchanged, as ociperlimab was a very small component of our valuation.”

In its SEC filing, BeiGene said it will “carefully evaluate all available data to inform future development opportunities with ociperlimab.”

immunotherapy
pharma