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Clinical Daily Summary

Clinical Daily Summary: What Happened on October 27, 2026

Artiva ends AlloNK program after two deaths and plans 94% workforce cut

Bristol Myers Squibb disclosed a septic pneumonia death in its multiple sclerosis CAR T trial. Iza-bren more than doubled median progression-free survival in a Phase 3 lung cancer study.

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Covers October 26 and October 27. There was no summary on October 26.

Today in brief

Artiva ended AlloNK development after two deaths in a Phase 2a autoimmune-disease trial. Longer follow-up did not show the response durability the company considered necessary to continue.123 It plans to cut about 94% of its workforce and is weighing a merger, sale, asset licensing, or dissolution.12

A participant died from septic pneumonia after receiving Bristol Myers Squibb’s zola-cel in a Phase 1 multiple sclerosis trial. BMS said it could not determine whether the treatment contributed.456 In a Phase 3 lung cancer trial, iza-bren extended median progression-free survival to 11.1 months, versus 5.7 months with chemotherapy. Overall survival data were immature.78

Artiva ends AlloNK development and plans deep staff cuts

Artiva discontinued AlloNK, its natural killer cell therapy, after two participants died in a Phase 2a trial for autoimmune diseases.12 The company said longer follow-up showed B-cell depletion and clinical activity, but not enough response durability to support continued development.13

According to Artiva, an investigator and independent safety reviewers judged one fatal neurological event likely linked to fludarabine toxicity.123 The investigator considered the second death unrelated to AlloNK or other treatment components. Its cause remained unknown, the company said.123 After the first death, the FDA requested that enrollment and dosing stop. Artiva also paused plans for a Phase 3 trial.23

Artiva plans to cut about 94% of its workforce, with the reductions expected to finish in the first quarter of 2027.12 It is weighing a merger, sale, asset licensing, or dissolution. The company reported preliminary cash, equivalents, and investments of $319.1 million at September 30.12

Iza-bren extends progression-free survival in EGFR-mutated lung cancer

In the Phase 3 PANKU-Lung01 trial, iza-bren extended median progression-free survival to 11.1 months, versus 5.7 months with platinum-based chemotherapy.78 The China-based study enrolled people with previously treated, EGFR-mutated non-small cell lung cancer. Blinded independent review found a hazard ratio of 0.40.7 Confirmed response rates were 60.2% with iza-bren and 34.5% with chemotherapy.78

Overall survival results were immature, though the companies described a favorable trend.7 Two people receiving iza-bren developed interstitial lung disease, one Grade 1 and one Grade 3. The companies reported no new safety signals.7 Iza-bren has FDA designation for this setting but is not approved for any indication.78

BMS reports septic pneumonia death in multiple sclerosis CAR T trial

A participant in Bristol Myers Squibb’s Phase 1 Breakfree-2 trial died from septic pneumonia 44 days after receiving zola-cel.456 The participant developed delayed motor symptoms that persisted despite corticosteroids and intravenous immunoglobulin, then received high-dose cyclophosphamide before developing the infection.456 BMS said other complications and the participant’s extensive prior treatment made it impossible to establish whether zola-cel caused the death.45

The death occurred after the study’s data cutoff. BMS said it was the only Grade 5 event among 190 participants in its Phase 1 zola-cel autoimmune-disease programs.46 BMS said it notified investigators and regulators, and that a study safety committee reviewed the case.4 A data monitoring committee determined that the multiple sclerosis cohorts could continue after the Breakfree program restarts.4

At the higher dose, six of seven evaluable participants with relapsing disease met criteria for no evidence of disease activity at 26 weeks or later.56 In the evaluable progressive-disease group, 22 of 24 had no worsening disability, and all 24 had no new MRI activity.56 These interim efficacy findings came from small groups in a study without a control arm. The conference results had not undergone peer review.6

Sac-TMT improves survival in previously treated endometrial cancer

In the Phase 3 TroFuse-005 trial, sacituzumab tirumotecan, or sac-TMT, extended median overall survival to 19.0 months, compared with 12.1 months on chemotherapy.910 The trial enrolled 776 patients whose advanced endometrial cancer had progressed after platinum chemotherapy and anti-PD-1 or anti-PD-L1 immunotherapy.910 The risk of death was 32% lower with sac-TMT. Median progression-free survival was 7.2 months, versus 3.9 months with chemotherapy.910

Tumors responded in 35.1% of patients receiving sac-TMT and 17.3% receiving chemotherapy.910 Grade 3 or higher treatment-related adverse events occurred in 54.4% and 41.4% of patients, respectively.910 The FDA accepted the drug’s application for priority review, with an action date of June 15, 2027.9

Moderna and Merck plan 2027 filing after melanoma vaccine trial

Moderna and Merck’s personalized mRNA therapy intismeran reduced the risk of melanoma returning in a pivotal Phase 3 trial.111213 Moderna CEO Stéphane Bancel said the companies expect to file for FDA approval in 2027 and are preparing to test the treatment in other cancers.12 Why the vaccine lowered recurrence risk remains unclear.13

Also worth knowing

  • Mirum said zilurgisertib reduced average bone-lesion volume by 8.09 cm³ over 24 weeks in children with fibrodysplasia ossificans progressiva. The placebo group’s volume rose by 9.14 cm³. Mirum plans to discuss the results with the FDA and seek an age-group expansion in 2027.14

  • Enanta dosed the first participant in RESOLVE, a Phase 2b/3 trial of zelicapavir in high-risk adults with confirmed respiratory syncytial virus infection. Initial Phase 2b results are expected in 2027.15

  • Immatics reported a 32% confirmed response rate for IMA402 among patients with high PRAME expression. The Phase 1b study was small and uncontrolled.1617

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    In a China-based Phase 3 osteosarcoma trial, GSK and Hansoh reported median progression-free survival of 5.5 months with risvutatug rezetecan, versus 1.4 months with chemotherapy. Grade 3 or higher treatment-related adverse events occurred in 93% and 83% of patients, respectively.818

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    Aclaris reported early Phase 1b findings for ATI-052 in atopic dermatitis and asthma. In the skin-disease trial, EASI scores improved 45% versus placebo at day 57.19

  • Before bladder-cancer surgery, five of 15 evaluable patients given visugromab plus nivolumab had a pathological complete response, compared with one of 13 given nivolumab plus placebo.20

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