Novartis and Beigene End the Partnership on TIGIT oncology asset

On July 11th, 2023, BeiGene announced through SEC filings that they have mutually agreed with Novartis to terminate their option deal (from December 2021) on ociperlimab, a TIGIT asset. The details of the announcement include:

• BeiGene Switzerland will regain the full global rights to develop, manufacture and commercialize ociperlimab as part of the “Termination Agreement”
• Novartis have declined the option to pay up to $700 mil as part of the agreement to acquire the rights to the drug in the U.S., Europe, Japan and other territories by late 2023
• BeiGene will continue the enrollment for their P3 AdvanTIG-302 trial of ociperlimab + tislelizumab (PD-1) in 1L Nsq/Sq PD-L1 ≥ 50% locally advanced, unresectable or metastatic NSCLC (w/o AGAs)

However, Novartis has decided to terminate their P3 AdvanTIG-301 trial of ociperlimab + tislelizumab vs durvalumab following cCRT in stage III unresectable NSCLC

Highlights and Implications:

• ociperlimab is currently on track for approval in Q3 2025 (if results are positive) in 1L mNSCLC
  • Several big oncology players (e.g., Roche, Merck, Beigene, and AstraZeneca) remain committed to the TIGIT field, and many of them look to the results of SKYSCRAPER-01 as a catalyst to watch for the future of TIGIT
  • Despite multiple ongoing trials ahead of dom in unresectable NSCLC, the cancellation of oci’s P3 trial in unresectable NSCLC creates an opportunity to move into unresectable NSCLC with less competition (pending results of PACIFIC-8)
    • P3 SKYSCRAPER-03: atezo + tira (anti-TIGIT) Maintenance following CRT in unresectable Stage III NSCLC (CI estimate top-line results in 1H 2024)
    • P3 KEYVIBE-006: pembro + vibo (anti-TIGIT) + CRT in unresectable Stage III NSCLC (CI estimate top-line results in H1 2026)
    • P2 ARTEMIDE-01: rilvegostomig (PD-1/TIGIT bispecific) in unresectable or mNSCLC (AstraZeneca recently committed to a P3 start in 2023)
• Because Novartis had previously announced the large upcoming milestone amounts and recent less optimistic messaging around the program, the termination of the agreement is relatively unsurprising, and Novartis has hinted at looking to change strategic directions
  • Per the agreement, Novartis needed to decide whether to opt-in with up to an additional $700 mil payment by mid-2023
    • It was also announced this week that Novartis instead reached an agreement for $400 mil with Samsung Biologics this week to bolster biosimilar efforts
  • A Novartis spokesperson highlighted to Fierce Biotech that this decision was made after evaluating “the totality of the current information, including phase 2 data, benefit/risk, competitive space, timing, development programs, and future investments”
  • Novartis hinted at the overall lowered expectation of TIGIT programs globally after the disappointing phase 3 SKYSCRAPER-01 study on Roche's tiragolumab, follow-up negative results in other TIGIT programs (e.g., Merck's KEYVIBE-002), and when they failed to initiate the planned P3 study for oci in solid tumors last year
• Following the announcement, Beigene remains optimistic in the TIGIT program and will continue to move forward with its development plans
  • P3 AdvanTIG-301: oci (TIGIT) + tisle (PD-1) maintenance following CRT in PD-L1-positive unresectable Stage III NSCLC will be terminated, per the announcement
  • P3 AdvanTIG-302: oci (TIGIT) + tisle (PD-1) in 1L Nsq/Sq PD-L1 ≥ 50% locally advanced, unresectable or metastatic NSCLC (w/o AGAs) will continue enrollment (CI estimates top-line results in H2 2024)
  • P3 AdvanTIG-306: oci (TIGIT) + tisle (PD-1) + chemo in 1L all-comer mNSCLC w/o AGAs (CI estimates top-line results in H2 2026)
  • Beigene will carefully reevaluate all oci development in future indications, including five previously announced P2 trials in ESCC/CC/HCC/SCLC/NSCLC, with some data to be shared later this year to guide further R&D in TIGIT.
    • Of note, BeiGene will be holding an R&D IR event on July 18, 2023