Clinical Daily Summary: What Happened on October 7, 2026

Zipalertinib combination improved progression-free survival in Phase 3

Taiho Oncology’s chief medical officer, Harold Keer, said the zipalertinib and chemotherapy combination cut the risk of disease progression or death by half compared with chemotherapy alone in REZILIENT3.1 Median progression-free survival was 14.5 months with the combination and 8.5 months with chemotherapy alone.1

Overall-survival results remain immature, and median survival could not yet be estimated in either group.1 After a median follow-up of 10.9 months, 24 of 140 patients receiving the combination had died, compared with 31 of 139 receiving chemotherapy alone.1 Keer said 64.2% of patients initially assigned to chemotherapy switched to zipalertinib after progression, potentially narrowing the observed survival difference.1

The combination produced more adverse events, mostly bone-marrow suppression, which Keer said was more pronounced during the first four treatment cycles and managed with dose changes or discontinuation.1 Three patients in the combination group had treatment-related deaths, compared with none in the chemotherapy group.1 The trial is continuing, with later analyses planned as more progression or survival events accrue.1

Amplio study found a methotrexate biomarker increase, not clinical benefit

Amplio Pharma said one dose of NovoBioJect increased intracellular long-chain methotrexate polyglutamates by 38% versus methotrexate alone in a 12-person Phase 1b study.2 The open-label study enrolled people with rheumatoid arthritis taking stable weekly methotrexate and assessed safety, drug exposure and biomarker response, not clinical efficacy.2

The company reported mild injection-site reactions that varied by dose and no other treatment-related adverse events.2 Amplio plans a roughly 100-person, 12-week Phase 2a comparison with methotrexate alone, targeting a 2027 start if it secures financing and regulatory approval.2 The company is seeking about €10 million in Series A funding for the program.2

Viking tests oral and injectable maintenance schedules for VK2735

Viking Therapeutics began the second part of a study testing oral and less frequent injectable VK2735 schedules to maintain weight loss.35 About 195 adults with obesity receive weekly injections of VK2735 or placebo for 21 weeks, then follow a maintenance regimen through week 33.35 The study formally assesses safety, tolerability and drug exposure, with weight change as an exploratory measure.5

In the first part, about 180 participants lost an average of 16% to 19% of their weight after 21 weeks of injections, compared with about 0% on placebo.5 During the following 12-week maintenance period, participants retained as much as 97% of their initial weight loss with injections every other week and 90% with monthly injections, versus 61% after switching to placebo.5 Viking expects to report results from the second part in 2027.35

Enliven and FDA agree on relcobatinib Phase 3 trial design

Enliven Therapeutics and the FDA agreed on the final protocol for ENABLE-2, a planned Phase 3 study of relcobatinib in adults with chronic myeloid leukemia previously treated with at least one tyrosine kinase inhibitor.4 The trial is expected to compare once-daily relcobatinib with a second-generation tyrosine kinase inhibitor selected by the investigator and enroll about 450 participants.4

The primary endpoint is major molecular response at week 24, with the same measure at week 96 as a key secondary endpoint.4 Enliven plans to begin enrollment before the end of 2026.4

Also worth knowing

• P

  ViiV said Cabenuva improved control of HIV that remained unsuppressed.6

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  Avidity’s experimental Duchenne drug Del-zota remained under FDA review. Mutation-specific eligibility was estimated at about 7% of US patients, or roughly 900 people.7

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