Oncology biotech news: key moves to watch in September 2026 By Roohi Mariam Peter Add Labiotech as your Google Preferred Source 12 minutesmins September 16, 2026 12 minutesmins Share WhatsApp Twitter Linkedin Email Photo credits: National Cancer Institute (Unsplash) Add Labiotech as your Google Preferred Source Newsletter Signup - Under Article / In Page"*" indicates required fieldsLinkedInThis field is for validation purposes and should be left unchanged.Subscribe to our newsletter to get the latest biotech news!By clicking this I agree to receive Labiotech's newsletter and understand that my personal data will be processed according to the Privacy Policy.*Company name*Job title*Business email* Oncology Roundup is Labiotech’s new monthly selection of preclinical and clinical data reveals, research, regulatory decisions, fundraising, and deals announced in the oncology space over the past month. In this first edition of the Oncology Roundup, we selected 10 bulletins in the field that have caught our eye since mid-August 2026, from Rasonque’s approval for pancreatic cancer and Transgene’s cancer vaccine readout to DualityBio’s billion-dollar-deal with Genentech to develop antibody-drug conjugates. Table of contentsDualityBio signs ADC deal with Genentech At a glance: Genentech and DualityBio are collaborating to develop antibody-drug conjugates (ADCs). Shanghai-based DualityBio has an elaborate pipeline of ADCs, which were born out of the company’s four main technology platforms, namely, Duality Immune Toxin Antibody Conjugate (DITAC), Duality Innovative Bispecific Antibody Conjugate (DIBAC), Duality Unique Payload Antibody Conjugate (DUPAC), and Duality Immune-Modulating Antibody Conjugate (DIMAC). ADCs comprise a monoclonal antibody, which travels through the bloodstream to spot and bind to the antigens on cancer cells, a chemotherapy that kills cancer cells, and a linker molecule that connects the antibody and the chemotherapy together. The Chinese biotech’s lead candidate is the ADC, DB-1303, which targets HER2-positive cancers. It is currently in phase 3 trials and being co-developed with BioNTech. The recent Genentech collaboration will see the Roche-owned biopharma employ DualityBio’s DUPAC platform to develop new ADCs that are different from topoisomerase inhibitor-based ADCs. This platform is designed to help destroy tumors particularly in those people who don’t respond well to topoisomerase inhibitor–based ADCs. DualityBio will rake in $45 million upfront and more than $1 billion in aggregate development, regulatory, and commercial milestone payments across all the new programs. PMV Pharma’s rezatapopt shows promise in ovarian cancer trial At a glance: Rezatapopt is a small molecule in phase 2 studies for ovarian cancer. New Jersey-based PMV Pharmaceuticals’ small molecule rezatapopt could treat ovarian cancer, interim phase 2 data revealed. Rezatapopt is designed to restore the tumor-suppressor properties of p53 proteins. Mutations in the TP53 gene, which occur in more than 80% of ovarian cancers, lead to the silencing of p53 when a small pocket develops on the surface of the protein. The interim results showed that the drug candidate had a 46% overall response rate (ORR) and four patients out of 76 had complete responses. Moreover, 29 patients had partial responses. The median time to response was 1.3 months and for those who responded to the drug, this lasted for 10 months. Roughly 5% of patients have stopped taking the drug after they experienced grade one and two side effects, such as nausea and vomiting. This interim reveal is following data presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in Puerto Rico in April. Rezatapopt had a 44.4% ORR and induced an 8.2-month long response in patients. PMV got the U.S. Food and Drug Administration (FDA) nod to submit a new drug application (NDA), which it will do next year. Rezatapopt could fill a critical treatment gap for people with ovarian cancer for whom platinum-based chemotherapy doesn’t work. Anzu-cel developer Immatics nabs $150 million in public offering At a glance: Immatics has a cell therapy for melanoma in phase 3 trials. Immatics, headquartered in Tübingen, Germany, is developing its lead candidate anzu-cel, a cell therapy, in phase 3 studies. Anzu-cel was discovered to tackle the target PRAME, which is expressed in more than 50 cancers, including melanoma, lung, ovarian, breast, and endometrial cancer. The candidate is a TCR T-cell therapy, a type of immunotherapy where a patient’s own T cells are retrieved and genetically modified to recognize and destroy cancer cells – in the case of anzu-cel, to target PRAME. Patients’ white blood cells are taken, and the T cells are isolated from the blood. These cells are engineered to specifically detect the PRAME peptide present on the tumor cells. The process of manufacturing takes about seven to eight days. Suggested Articles Preclinical Pulse: The research catching our eye in September 2026 Eight oncology deals in 2026 spotlight where industry leaders are betting big Bladder cancer treatment: where are we standing in 2026? Top biotech deals in August 2026 The biggest biotech funding rounds in August 2026 Immatics’ $150 million public offering will help fund the clinical trials, including the ongoing phase 3 study of anzu-cel for second-line melanoma in patients who have already undergone treatment with immune checkpoint inhibitors, a phase 2 study in uveal melanoma, a rare eye cancer, as well as the development of the company’s bispecific proteins for melanoma and gynecological cancers. Transgene’s cancer vaccine TG4050 leads to 100% three-year-survival At a glance: The candidate TG4050 is a viral-based vaccine for head and neck cancer in phase 1/2 trials. French company Transgene’s lead candidate TG4050 is a personalized cancer vaccine. It contains the Ankara virus that has been modified to encode up to 30 tumor neoantigens. These antigens were identified and selected using Japanese tech company NEC’s artificial intelligence system. When the vaccine is injected, the virus enters the patient’s cell where it instructs the cell to generate the neoantigens, which are presented on the surface of the immune cells to detect and attack tumor cells. A phase 1 study found that all the patients with head and neck cancer who got the vaccine stayed alive and show no symptoms of their cancer returning for three years. All the patients in the study were HPV-negative and had previously undergone surgery. This is an encouraging sign for the neoantigen vaccine approach, which is being studied in the clinic by several researchers but is yet to receive clearance from regulators. Johnson & Johnson’s Tecvayli approved by EC as a combination therapy for multiple myeloma At a glance: The European Commission (EC) has approved the antibody Tecvayli in combination with another monoclonal antibody to treat multiple myeloma. Tecvayli, also known as teclistamab, is an off-the-shelf antibody that is delivered subcutaneously to patients. When it enters the body, teclistamab redirects CD3-positive T cells – CD3 is a marker on the surface of T cells – to turn on the immune system to attack cancer cells. In multiple myeloma, a blood cancer that forms in plasma cells, cells express BCMA, which the antibody is designed to target. The EC first greenlit the drug as a monotherapy to treat multiple myeloma in patients who have previously received at least three treatments back in 2022. The recent clearance was over its use in combination with the monoclonal antibody daratumumab in patients whose cancer had worsened after at least one round of prior treatment. This combination therapy will see only daratumumab given to patients on the first day. Tecvayli will be administered on a step-up dosing schedule, where it will be given at increasing doses on specific days followed by weekly, biweekly, and then monthly maintenance doses. This regimen was also approved by the FDA in March. AbbVie’s multiple myeloma study reaps positive topline results for etentamig At a glance: The pharma giant AbbVie’s T cell engager etentamig is in phase 3 trials for multiple myeloma. The American pharma AbbVie’s T cell engager etentamig binds to the CD3 receptor present on T cells as well as the BCMA antigens expressed on the surface of multiple myeloma cells, directing the T cells to destroy the cancer cells. Etentamig is engineered to bind to CD3 with reduced strength to reduce cytokine release syndrome (CRS) and other toxicities. It is administered monthly. Recently published study results revealed that the drug led to a 74% ORR in patients and the risk of the disease progressing or dying from the disease was 60% lower compared to standard available therapies. Nearly 90% of patient were alive after a year of treatment with etentamig compared to 72% of patients on standards of care. One patient experienced neurotoxicity syndrome but no grade two or higher events were reported. The data will be presented at the International Myeloma Society Annual Meeting, taking place in Glasgow, Scotland later this month. Revolution Medicines’ Rasonque bags FDA approval At a glance: The FDA has approved the RAS inhibitor Rasonque for advanced pancreatic cancer. In pancreatic cancer, RAS is the dominant oncogenic driver, present in more than 90% of pancreatic ductal adenocarcinomas (PDAC), the most common form of the disease. This makes it an ideal therapeutic target. Daraxonrasib, known by its brand name Rasonque, is designed to target RAS, which in mutated cancer cells, is stuck in the ‘on’ state, as opposed to the switching on-off state in normal cells. Revolution Medicines’ oral small molecule is designed to turn off RAS, suppressing tumor growth and triggering cancer cell death. Rasonque won FDA approval to address pancreatic cancer three weeks ago after a phase 3 trial in 500 people found that the drug not only doubled overall survival from 6.6 months to 13.2 months but also doubled progression-free survival compared to chemotherapy. The data was presented at the American Society of Clinical Oncology (ASCO) in Illinois earlier this year. This marks the first RAS inhibitor to nab the FDA nod for pancreatic cancer. The Rasonque developer, California-based Revolution Medicines, wants to expand the drug’s reach across solid tumors. Hutchmed and GSK join forces to develop ADC At a glance: Hutchmed and GSK have forged a $1.295 billion licensing deal over the ADC HMPL-A830 to treat colorectal, pancreatic, and lung cancers. Hong Kong-based Hutchmed’s HMPL-A830 is not a typical ADC that carries cytotoxic payloads; instead, it links a KRAS small molecule inhibitor payload to the antibody. KRAS mutations are found in most pancreatic cancers, 44% of colorectal cancers, and 34% of lung cancers, so inhibiting the protein targets a wide patient population. Meanwhile, the antibody targets the protein EGFR, which is present on cell surfaces and controls cell growth and survival. British giant GSK has bet on HMPL-A830, paying $110 million upfront to Hutchmed, with the potential for the latter to gain up to $1.295 billion in milestone payments. Hutchmed will continue to develop the ADC in China, Hong Kong, Macau, and Taiwan, while GSK will take over the reins to develop and potentially commercialize HMPL-A830 in the rest of the world. The biotech will hand over HMPL-A830 to GSK after phase 1 studies, which will begin later this year. Hutchmed reveals combination therapy of tyrosine kinase inhibitors is better than monotherapy At a glance: Hutchmed’s tyrosine kinase inhibitor shows promise in combination with Tagrisso in phase 3 trial in patients with non-small cell lung cancer. Hutchmed’s second win last month was over its MET tyrosine kinase inhibitor, Orpathys, also known as savolitinib. As the name suggests, tyrosine kinase inhibitors block tyrosine kinases. These are enzymes that normally regulate cell growth and survival, but in cancer, drive unchecked cell division. Unlike other tyrosine kinase inhibitors, Orpathys targets the receptor c-MET, which steers the tyrosine kinase pathway. A phase 3 trial evaluated whether the combination of two tyrosine kinase inhibitors, savolitinib and AstraZeneca’s Tagrisso, was more effective than Tagrisso alone in patients with non-small cell lung cancer (NSCLC), and results came out positive. The trial in China recruited patients who had never had treatment before. The company also revealed that the combination saw a “a very encouraging clinical benefit in overall survival” in two patient groups, one where MET is overexpressed and the second, a randomized intention-to-treat cohort. Jointly developed by Hutchmed and AstraZeneca, Orpathys was cleared to treat NSCLC and gastric cancer by China’s National Medical Products Administration (NMPA) in 2025 and July this year, respectively. Now, the two are eyeing the combination therapy approval. AstraZeneca discloses phase 3 NSCLC data for Enhertu At a glance: AstraZeneca and Daiichi Sankyo’s ADC Enhertu is in phase 3 trials for NSCLC. As with most ADCs, Enhertu contains a monoclonal antibody, linker molecule, and drug payload. Enhertu’s monoclonal antibody targets the protein HER2, which can be overexpressed in certain cancers, accounting for about 20% of breast cancer cases. The drug payload is a topoisomerase I inhibitor. The role of the topoisomerase enzyme is to unwind and cut tangled DNA so that a cell can read and copy its genetic code during cell division. But in cancer cells, this is not a helpful mechanism. Inhibiting the enzyme prevents the DNA from being pieced back together, halting cancer cell division. Enhertu’s developers AstraZeneca and Daiichi Sankyo put Enhertu through a phase 3 trial to see if it is effective as a first line treatment against HER2-positive NSCLC. The drug was found to cut the risk of disease progression and death by 37% compared to treatment with the monoclonal antibody Keytruda and chemotherapy. The drug had a 70% ORR compared to 44.5% with the Keytruda-chemotherapy combination. The drug response lasted for 13.4 months in contrast to the combination therapy’s 9.7 months. However, patients in the Keytruda-chemo group lived longer. The median for the Keytruda-chemo arm was around 33.1 months compared to 29.3 months with Enhertu. This could come in the way of an FDA approval for the indication. Enhertu was first greenlit for HER2-positive breast cancer in 2019 and has since received further authorizations from the FDA. On top of these mixed results, AstraZeneca took a blow last week when its breast cancer pill Etcamah failed a phase 3 trial. What should we cover next month? Oncology Roundup will return next month with a new selection of trial readouts, fundraising, and licensing deals in oncology that have caught our attention. If you are working on, or have come across, research in the oncology field that is worth featuring in a future edition, let us know. Preclinical and clinical data announcements are welcome. This article is reserved for subscribers Subscribe for free to continue reading.Enter your details to log in or subscribe. Email Company name Job title Continue Readingor Continue with Microsoft Continue with LinkedIn By continuing, I agree to receive Labiotech's newsletter and understand that my personal data will be processed according to the Privacy Policy. Organoids in cancer research: Paving the way for faster drug development across cancer indications This webinar explores how patient-derived organoids (PDOs) are redefining oncology research. Discover how advanced, well-characterized models empower researchers to streamline candidate selection, accelerate orphan drug programs, and deliver transformative therapies to patients faster than ever. Watch now Explore other topics: AntibodiesAntibody-drug conjugatesCancerSmall molecules ADVERTISEMENT