Tigit mystery deepens with Merck's clinical expansion

Renewed enthusiasm has marked Tigit as a hot target in immuno-oncology, but developments have taken place almost in secret. In January Roche started a huge pivotal programme with tiragolumab, and told Vantage it had waited until the last possible moment to disclose this so as not to tip off its biggest rival, Merck & Co. For its part the latter company has quietly been expanding its phase I trial of MK-7684, which initially targeted 120 subjects but now seeks to enrol 432. And just last week Merck fired its own shot at Roche, listing on clinicaltrials.gov three new mid-stage studies that look like they could support approval of its Tigit combos across three melanoma settings. Roche has just listed the Skyskraper-01 and 04 tiragolumab trials in NSCLC and cervical cancer respectively, and five more settings have yet to be revealed. Still unknown is what clinical data have driven such enthusiasm; Evercore ISI analysts last week wrote that “it’s clear there is a signal ... but we haven’t got additional disclosures yet”. Roche was due to present early Tigit data at April’s AACR, but the meeting has been rescheduled owing to the Covid-19 pandemic.

Selected industry studies targeting Tigit
Project Company Trial Timing
Phase III
Tiragolumab Roche Skyscraper-01, Tecentriq combo in 1L PD-L1+ NSCLC 500 subjects; ends 2022
Skyscraper-02, Tecentriq + chemo combo in 1L SCLC 400 subjects; ends 2023
Phase II
MK-7684 Merck & Co Keynote-01A, Keytruda + chemo combo in 1L NSCLC 90 subjects; started 15 Jan 2020
Keynote-U02 (substudy A), Keytruda + MK-1308 (CTLA-4) combo in PD-1-refractory melanoma 200 subjects; starts Apr 2020
Keynote-U02 (substudy B), Keytruda combo in 1L melanoma 135 subjects; starts Apr 2020
Keynote-U02 (substudy C), Keytruda combo in neoadjuvant melanoma 65 subjects; starts Apr 2020
BMS-986207 Bristol-Myers Squibb Monotherapy and Opdivo combo in various tumours 170 subjects; ends Dec 2022
AB154 Arcus Biosciences Combo with PD-1 +/- A2A in 1L NSCLC 150 subjects; started Jan 2020
Phase I
ASP8374 Astellas (ex Potenza) Monotherapy and Keytruda combo in various tumours 363 subjects; ends Jul 2021
BGB-A1217 Beigene Tislelizumab combo in various tumours 39 subjects; ends Apr 2021
SGN-TGT Seattle Genetics Monotherapy and PD-(L)1 combo in various tumours 111 subjetcs; starts 20 Mar 2020
E0S884448 Iteos Therapeutics Monotherapy in solid tumours Phase 1 just announced
Etigilimab Mereo Biopharma Monotherapy and Opdivo combo in various trumours Marked "terminated" on clinicaltrials.gov
COM902 Compugen IND cleared to start phase 1 in 2020
IBI-939 Innovent IND cleared to start phase 1 in China
AGEN1307 Agenus
Source: EvaluatePharma & company presentations.

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