2026年10月肿瘤生物科技动态：FDA批准与关键交易一览

Oncology Roundup is Labiotech’s monthly selection of preclinical and clinical results, research developments, regulatory decisions, fundraising, and deals announced in oncology over the past month. 

In October, we selected nine oncology news that caught our attention since mid-September 2026, from new Food and Drug Administration (FDA) approvals for Pfizer’s Tukysa and ImmunityBio’s Anktiva to promising early results for a KRAS-targeting treatment in pancreatic cancer and a $1.65 billion radiopharmaceutical merger agreement between Telix and ITM. 

Pfizer’s Tukysa gains FDA approval for HER2-positive breast cancer maintenance therapy 

At a glance: The FDA has approved Pfizer’s HER2-targeted tyrosine kinase inhibitor Tukysa as part of a maintenance regimen for advanced HER2-positive breast cancer. 

Pfizer’s Tukysa (tucatinib) is an oral drug that blocks HER2. It was previously approved for patients with advanced HER2-positive breast cancer who had received earlier treatments. The new approval allows Tukysa to be used sooner, alongside the HER2-targeting antibodies trastuzumab and pertuzumab, as maintenance therapy after initial chemotherapy. The aim is to keep the cancer under control for longer without continuing chemotherapy. 

The FDA approved the combination on October 7, based on a 654-patient phase 3 trial. According to results published in the Journal of Clinical Oncology, adding Tukysa extended median progression-free survival from 16.3 to 24.9 months, reducing the risk of disease progression or death by 36%. However, severe adverse events were more frequent with Tukysa, particularly elevated liver enzymes and diarrhea.  

Genentech’s Tecentriq approved for stage 3 colon cancer 

At a glance: The FDA has approved Genentech’s PD-L1 inhibitor Tecentriq alongside chemotherapy for patients with stage 3 mismatch repair-deficient colon cancer. 

Genentech’s Tecentriq (atezolizumab) has become an adjuvant treatment option for patients with stage 3 colon cancer whose tumors have deficient mismatch repair (dMMR). These tumors accumulate mutations because their DNA repair machinery is impaired, making them particularly susceptible to immune checkpoint inhibition. While immunotherapy is already established in advanced dMMR colorectal cancer, the new approval extends its use to patients who have undergone surgery, with the aim of reducing the risk of recurrence. 

The approval follows the phase 3 ATOMIC trial, which found that 86.3% of patients receiving Tecentriq alongside chemotherapy were disease-free after three years, compared with 76.2% of those receiving chemotherapy alone. However, the results also showed higher rates of grade 3 or 4 adverse events with the combination (84.1% versus 71.9%). Roche is seeking to expand the treatment’s approval to other markets, including Europe. 

ImmunityBio’s Anktiva gains expanded FDA approval in bladder cancer 

At a glance: The FDA has expanded the approval of ImmunityBio’s IL-15-based immunotherapy Anktiva to include high-grade papillary-only non-muscle-invasive bladder cancer that no longer responds to BCG treatment. 

ImmunityBio’s Anktiva (nogapendekin alfa inbakicept) stimulates immune cells involved in attacking tumors and is administered directly into the bladder alongside Bacillus Calmette-Guérin (BCG). Originally approved in 2024 for patients with carcinoma in situ (CIS), with or without papillary tumors, the treatment can now also be used in patients with high-grade papillary-only disease. This broadens the nonsurgical treatment options for patients whose cancer persists or returns despite BCG therapy. 

What makes this October approval unusual is the FDA’s decision to extend existing clinical evidence to a related form of bladder cancer. In the earlier QUILT-3.032 trial, 62% of patients with CIS achieved a complete response, but these results were not obtained in the newly approved papillary-only population. The agency considered the biological and clinical similarities between the two forms sufficient to support the expansion. It is now developing guidance that could allow similar approaches in future bladder cancer drug approvals. 

Heidelberg Pharma reports early clinical results for amanitin-based ADC 

At a glance: Heidelberg Pharma’s BCMA-targeting antibody-drug conjugate HDP-101 has completed phase 1 dose escalation in relapsed or refractory multiple myeloma. 

German biotech Heidelberg Pharma is developing pamlectabart tismanitin (HDP-101), an antibody-drug conjugate (ADC) that uses a toxin derived from the death cap mushroom. The drug targets BCMA, a protein found on myeloma cells, to deliver amanitin, which blocks RNA polymerase 2 and prevents cells from producing RNA. This mechanism could also affect cancer cells that are not actively dividing. 

At the International Myeloma Society meeting in September, Heidelberg reported a 42% overall response rate among 31 evaluable patients in higher-dose cohorts, including three stringent complete responses. A phase 2a expansion is now underway to assess the treatment in a larger group of patients with heavily pretreated multiple myeloma. 

Bristol Myers Squibb’s radiopharmaceutical RYZ101 meets phase 3 endpoint 

At a glance: Bristol Myers Squibb’s actinium-225-based radiopharmaceutical RYZ101 has met its phase 3 primary endpoint in advanced gastroenteropancreatic neuroendocrine tumors. 

RYZ101, developed by Bristol Myers Squibb subsidiary RayzeBio, targets somatostatin receptors found on many gastroenteropancreatic neuroendocrine tumors (GEP-NETs), delivering radioactive actinium-225 directly to cancer cells. Existing lutetium-177-based therapies emit beta radiation, but actinium-225 releases short-range, high-energy alpha particles that damage cancer cell DNA. The treatment is being developed for patients whose disease has progressed despite previous lutetium-based therapy, a setting with limited treatment options. 

In the phase 3 ACTION-1 trial, RYZ101 significantly improved progression-free survival compared with standard treatments, according to topline results announced on October 12. Bristol Myers Squibb has not yet disclosed the details of the benefit, but reported that the safety findings were consistent with the drug’s known profile. The company plans to discuss the results with the FDA ahead of a potential regulatory submission, while detailed data are expected at a future medical meeting. 

BioNTech’s mRNA cancer immunotherapy misses phase 2/3 trial endpoint 

At a glance: BioNTech’s mRNA-based immunotherapy BNT113 failed to improve progression-free survival in a phase 2/3 trial involving patients with HPV16-positive head and neck cancer. 

BioNTech suffered a setback in its cancer vaccine program after BNT113, combined with Merck’s Keytruda (pembrolizumab), failed to significantly delay disease progression compared with Keytruda alone. BNT113 is designed to stimulate an immune response against two proteins, E6 and E7, produced by human papillomavirus type 16 (HPV16).  

BioNTech has not disclosed detailed efficacy figures, and the study will continue to assess its other primary endpoint, overall survival. A significant survival benefit could still support a positive trial outcome, although the initial findings leave the treatment’s clinical benefit uncertain. 

Verastem’s KRAS G12D inhibitor shows early promise in pancreatic cancer 

At a glance: Verastem reported encouraging early results for VS-7375, an oral KRAS G12D inhibitor being developed for pancreatic cancer. 

Four of eight patients receiving Verastem’s VS-7375 as second-line treatment for metastatic pancreatic cancer experienced a confirmed tumor response, according tophase 1/2 results released in October. Across a broader group of 22 previously treated patients, the response rate was 41%. KRAS G12D is one of the most common mutations driving pancreatic cancer, yet no treatment specifically targeting it has been approved. 

Originally developed by China’s GenFleet Therapeutics, VS-7375 is designed to inhibit KRAS G12D in both its active and inactive states. The results remain preliminary, with relatively few patients and limited follow-up, but Verastem is already preparing a phase 3 trial in first-line metastatic pancreatic cancer. The company has agreed on the trial design with the FDA and expects to begin enrollment before the end of 2026. 

Telix and ITM agree to $1.65 billion radiopharmaceutical merger 

At a glance: Australian radiopharmaceutical company Telix has agreed to acquire Germany’s ITM in a deal combining cancer imaging, therapeutic development and radioisotope manufacturing. 

Securing a reliable supply of radioactive isotopes is more important than ever as more radiopharmaceutical cancer treatments advance toward commercialization. Telix announced an agreement on September 21 to merge with ITM Isotope Technologies Munich, one of the leading manufacturers of therapeutic radioisotopes. Telix already markets radiopharmaceutical imaging products and has several cancer therapies in late-stage development. ITM brings an established isotope production business, including lutetium-177, with $273 million in revenue in 2025. The combination would give Telix greater control over the supply chain needed to manufacture and deliver its treatments. 

The agreement also expands Telix’s clinical pipeline. ITM’s lead candidate, ITM-11, is a lutetium-177-based treatment for gastroenteropancreatic neuroendocrine tumors that has reported positive phase 3 results. Telix will acquire ITM for $1.65 billion upfront with up to $700 million more tied to future regulatory approvals and sales milestones for ITM-11. The merger is expected to close by the end of 2026. 

Vir Biotechnology signs $1.88 billion licensing agreement with Gilead 

At a glance: Vir Biotechnology has partnered with Gilead to develop three masked T-cell engagers for solid tumors, in a deal worth up to $1.88 billion. 

Vir Biotechnology has secured its second major partnership of 2026 for its PRO-XTEN platform, following an earlier agreement with Astellas. This time, Gilead is licensing three experimental T-cell engagers designed to become active primarily within tumors. The molecules carry protective masks that are intended to be removed by enzymes in the tumor microenvironment, potentially limiting the toxicity that has complicated the development of T-cell engagers for solid cancers. 

The agreement gives Gilead responsibility for clinical development and commercialization, while Vir will handle the initial discovery work. Vir will receive $90 million upfront, including a $25 million equity investment, with another $1.79 billion available through milestone payments. Neither company has disclosed the targets of the three programs, which are still at the discovery stage. 

What should we cover next month? 

Oncology Roundup will return next month with another selection of clinical developments, research findings, and business deals that have caught our attention. 

If you’re working on, or have come across, oncology research worth featuring in a future edition, let us know. We welcome both preclinical and clinical developments.