On August 31, 2026, the US Court of Appeals for the Federal Circuit affirmed a Delaware federal court judgment, holding that claims in Exelixis patents US 11,091,439, US 11,091,440 and US 11,098,015 covering the crystalline salt cabozantinib (L)-malate, its formulations and treatment methods meet the written description requirement of 35 U.S.C. §112(a). As a result, the earliest launch of MSN's generic of Cabometyx is pushed to 2030.
On August 26, 2026, the FDA approved Revolution Medicines' Rasonque (daraxonrasib, formerly RMC-6236) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior line of systemic therapy. It is the first FDA-approved targeted therapy aimed at the active-state RAS(ON) protein family. The RAS(ON) molecular glue approval marks one of the biggest clinical advances in pancreatic cancer in nearly a decade.
Adding 177Lu-PSMA-617 to androgen deprivation therapy plus an androgen receptor pathway inhibitor reduced the relative risk of radiographic progression or death by 28% in PSMA-positive metastatic APMN/S prostate cancer, meeting the primary endpoint of prolonged radiographic progression-free survival. In the phase 3 PSMAddition trial, 572 patients per arm were randomised; radiographic progression or death occurred in 24% of the 177Lu-PSMA-617 arm versus 30% of the control arm. Grade 3 or worse adverse events occurred in 51% versus 43%, with dry mouth the most common event in the 177Lu-PSMA-617 arm.
Bristol Myers Squibb won accelerated approval for iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase (Darzalex Faspro) and dexamethasone for multiple myeloma patients who have received at least one prior line of therapy. Iberdomide is the newest of BMS's molecular glue degraders to reach the market.
LZTFL1 amplifies ferroptosis by promoting oxidation of G6PD, which limits NADPH production and impairs glutathione regeneration; GSH depletion then boosts LZTFL1 translation through an AKT-mTOR-eIF4E feedforward loop. In vivo, the LZTFL1-FHOD1-G6PD axis sensitized multiple tumor models, including patient-derived xenografts, suppressing tumor growth and prolonging survival. LZTFL1 restored cisplatin sensitivity in resistant lung and ovarian cancer cells and predicted better survival in lung adenocarcinoma patients.
Tumors release the antioxidant enzyme peroxiredoxin 1 (PRDX1) into their environment, where it deprives T cells of reactive oxygen species needed for T cell receptor signaling and effector function. Prdx1 is up-regulated during cancer immunoediting, and its loss within tumors enhances antitumor immunity and responses to immunotherapy. The work identifies a redox-dependent mechanism of tumor immunosuppression that may be targetable therapeutically.
Ivonescimab from Akesf outperformed pembrolizumab in the phase III HARMONi-2 head-to-head trial, meeting the primary endpoint of progression-free survival at interim analysis with a statistically significant result. Median PFS was 11.14 months with ivonescimab versus 5.82 months with pembrolizumab, hazard ratio 0.51. HARMONi-2 is the first phase III study to show a significant positive result against pembrolizumab.
The FDA approved Revolution's RASONQUE (daraxonrasib), a once-daily oral tablet, for adults with metastatic pancreatic ductal adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multi-drug combination systemic therapy. The approval on 26 August 2026 came about 6.5 months ahead of the original FDA target date. Daraxonrasib is the first approved RAS(ON) multi-selective inhibitor and the first RAS-targeted drug for metastatic PDAC that broadly inhibits multiple RAS mutations.
China's National Healthcare Security Administration released version 3.0 of its DRG and DIP payment grouping schemes at a press conference on September 2, more than a month later than the planned July release. Core DRG groups rise from 409 in version 2.0 to 492, with detailed subgroups up from 634 to 825, while core DIP disease categories are cut from 9520 to 5125. The revision shifts weight toward complex cases such as oncology and critical illness and away from common conditions.
Ivonescimab, the PD-1xVEGF bispecific from Akeso and Summit, has met its overall survival endpoint in a head-to-head trial against Keytruda. The result follows a progression-free survival win reported about two years ago, which had positioned the drug and its class as the leading candidate to replace Keytruda. The overall survival finding, however, has drawn a far more measured reception.
Etentamig, AbbVie's bispecific T-cell engager, improved response rates and progression-free survival in patients with relapsed/refractory multiple myeloma in a phase 3 trial. The positive data, released Thursday, support the candidate as a treatment option in this setting.
The YEARS algorithm was as safe as direct computed tomographic pulmonary angiography (CTPA) for ruling out acute pulmonary embolism in patients with active cancer. In the per-protocol analysis, 5 of 282 patients (1.8%) managed by YEARS vs 15 of 273 (5.5%) by CTPA only had symptomatic venous thromboembolism or possible PE-related death within 90 days (absolute risk difference, -3.7%; upper bound of 99.9% CI, 1.4%), and 22% of YEARS patients avoided CTPA entirely. This challenges guideline advice to send all cancer patients with suspected PE straight to CTPA.
GSK has licensed Hutchmed's preclinical KRAS-EGFR antibody conjugate HMPL-A830, paying $110 million upfront in a deal worth up to $1.295 billion, excluding Mainland China, Hong Kong, Macau and Taiwan. The candidate delivers a KRAS inhibitor to EGFR-expressing tumors and is slated to enter trials later this year, initially in colorectal, pancreatic and lung cancer. Hutchmed will run Phase 1 trials, after which GSK takes over R&D and commercialization outside select Asian territories.
Why it matters: GSK is paying up to $1.295 billion for a preclinical first-in-class KRAS-EGFR candidate, a notable early-stage oncology licensing deal.
High CD8+ T-cell density is an independent prognostic factor for better disease-free and overall survival in sinonasal intestinal-type adenocarcinoma (59 tumors analyzed by immunohistochemistry, flow cytometry and transcriptomics). Tumor-infiltrating lymphocytes expressed PD1, TIGIT and TIM-3, and TIM-3 blockade in patient-derived explants increased tumor cell apoptosis, while tumors expressed CD155 but not PDL1 on tumor cells. Transcriptomics separated hot from cold tumor clusters with different prognoses and immunotherapy response scores, giving a rationale for immunotherapy trials in this wood dust-associated cancer with limited standard options.
Daraxonrasib (RMC-6236), an oral RAS(ON) multiselective inhibitor, showed antitumor activity in 136 previously treated patients with advanced RAS-mutant NSCLC: objective response occurred in 31% at doses of 120 mg or less, 34% at 160 to 220 mg, and 37% at 300 mg once daily. Adverse events of grade 3 or higher occurred in 54%, including four grade 5 events, with rash, diarrhea, nausea, vomiting, and mucositis or stomatitis each affecting at least 30% of patients.
Simcere Zaiming, the oncology innovation unit of Simcere Pharmaceutical, has granted Roche exclusive worldwide rights to develop, manufacture and commercialize SIM0660, a CD79a/CD19/CD3 trispecific antibody. Under the September 1 license deal, Simcere Zaiming is eligible for total payments of up to $1.53 billion, including $75 million upfront.
China's CDE has granted proposed priority review to MediLink Therapeutics' B7-H3 ADC YL201 (Tam-Peli) for recurrent small cell lung cancer after failure of initial platinum-based therapy, with the marketing application filed the same day, September 2. The filing, based on the phase 3 TAISHAN-302 trial, which met its overall survival primary endpoint, makes YL201 the first ADC to secure acceptance of a small cell lung cancer application on phase 3 data. Full efficacy and safety results will be presented orally at the 2026 WCLC Presidential Symposium; a prior priority-review filing in July covered third-line nasopharyngeal carcinoma.
CD8+ T cell antitumor immunity makes tumor cells more susceptible to cuproptosis: T cell-derived IFN-γ drives FDX1 transcription via the STAT1-IRF1 axis, while cuproptotic tumor cells act as immunogenic cell death that activates dendritic cells. Combining a cuproptosis inducer with anti-PD-L1 therapy overcame PD-L1 therapy resistance across multiple preclinical models. The work links antitumor immunity to cuproptosis and identifies a way to counter immunotherapy resistance.
Why it matters: It identifies a mechanism by which antitumor immunity and cuproptosis reinforce each other and a combination that reverses PD-L1 resistance in preclinical models.
Sequentially administered antibodies and ADCs bearing trans-cyclooctene and tetrazine moieties ligate in vivo to form functional antibody-ADC click constructs, removing the dependence on a single target antigen. In preclinical models of HER2 and EGFR co-expression, including tumours with low, ultralow, negative or heterogeneous HER2 expression and tumours resistant to or ineligible for conventional HER2-directed ADCs, the approach showed improved antitumour activity over standard ADC monotherapy and over antibody plus ADC combinations. The platform requires no extensive antibody re-engineering and extends to other receptor pairs.
Why it matters: It offers a modular route to overcoming antigen-heterogeneity-driven resistance to antibody-drug conjugates without antibody re-engineering.
Cyclin E-CDK2 phosphorylates BRD4 and controls its chromatin occupancy, a transcriptional role independent of the cell cycle. Cyclin E overexpression represses interferon-stimulated gene expression in cancer cells through BRD4 and promotes resistance to immunotherapy, while inhibiting CDK2 activity enhances responses to immune checkpoint blockade. The work positions CDK2 as a targetable driver of checkpoint blockade response.
