--- title: 'Clinical Daily Summary: What Happened on October 7, 2026' headline: Taiho’s zipalertinib combination extends progression-free survival in Phase 3 description: Amplio reported an early rheumatoid arthritis biomarker result, Viking began testing VK2735 maintenance schedules, and Enliven agreed on a leukemia trial design with the FDA. url: https://thebench.bio/news/clinical/2026-10-07 topic: clinical date: '2026-10-07' covers: - '2026-10-07' date_published: '2026-10-07T12:02:17Z' date_modified: '2026-10-07T12:02:17Z' sources: 7 publisher: The Bench (thebench.bio) --- # Clinical Daily Summary: What Happened on October 7, 2026 **Taiho’s zipalertinib combination extends progression-free survival in Phase 3** Amplio reported an early rheumatoid arthritis biomarker result, Viking began testing VK2735 maintenance schedules, and Enliven agreed on a leukemia trial design with the FDA. ## Today in brief Taiho Oncology reported median progression-free survival of 14.5 months with zipalertinib plus chemotherapy, compared with 8.5 months with chemotherapy alone, in Phase 3 REZILIENT3. [1] Overall-survival results remain immature, and three patients in the combination group had treatment-related deaths, compared with none in the chemotherapy group. [1] Amplio Pharma reported a 38% increase in a methotrexate biomarker in a 12-person rheumatoid arthritis study that did not assess clinical efficacy. [2] Viking began testing oral and injectable maintenance schedules for VK2735, and Enliven plans to start enrolling patients in its agreed Phase 3 leukemia trial before the end of 2026. [3] [4] ## 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. [3] [5] About 195 adults with obesity receive weekly injections of VK2735 or placebo for 21 weeks, then follow a maintenance regimen through week 33. [3] [5] 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. [3] [5] ## 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 - ViiV said Cabenuva improved control of HIV that remained unsuppressed. [6] - 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] ## The day in numbers - **14.5 vs. 8.5 months**: Median progression-free survival with zipalertinib plus chemotherapy versus chemotherapy alone in REZILIENT3. [1] - **38%**: Increase in intracellular methotrexate polyglutamates reported in Amplio’s 12-person Phase 1b study. [2] - **2027**: Year Viking expects to report results from VK2735’s maintenance study. [3] [5] ## Also published - [ACT Brief: FDA Transparency Roadmap, Radiopharmaceutical Trial Operations, and AI-Powered Enrollment Prediction](), Applied Clinical Trials - [The Unmet Needs That Will Define the Next Generation of GLP 1s: Q&A with Dr. Bo Liang](), Pharmaceutical Executive - [OCT SoCal 2026: Sound governance and collaboration lead the way as regulation percolates](), Clinical Trials Arena - [Where GLP-1 Development May be Headed](), Pharmaceutical Executive ## Sources 1. [Taiho’s CMO Dr Keer on positive REZILIENT3 data for zipalertinib combo](), Clinical Trials Arena, 2026-10-07 2. [Amplio reports early human data for novel methotrexate approach in rheumatoid arthritis](), Pharmafile, 2026-10-07 3. [Viking Therapeutics begins study of oral VK2735 for obesity](), Clinical Trials Arena, 2026-10-07 4. [FDA agrees ENABLE-2 Phase III trial design for Enliven’s relcobatinib](), Clinical Trials Arena, 2026-10-07 5. [Viking Begins Oral VK2735 Maintenance Trial in Obesity After Subcutaneous Dosing Data](), BioPharm International, 2026-10-06 6. [ViiV's Cabenuva enhances control of unsuppressed HIV](), pharmaphorum, 2026-10-07 7. [STAT+: In Duchenne muscular dystrophy, a promising therapy is available to a fortunate few](), STAT Biotech, 2026-10-07 --- The Bench wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: [5]: [6]: [7]: