Analysts believe Cullinan Therapeutics and Taiho Oncology can overcome the safety risks as zipalertinib “sets [a] new bar” for first-line treatment of a type of lung cancer. The candidate is already under review for the the second-line setting, with a decision expected by early next year.

Original title: “Despite 3 patient deaths, Cullinan-Taiho plan FDA filing for lung cancer pill on survival benefit”

BioNTech, Summit Therapeutics, GSK and Roche have made a splash at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer.

Original title: “Summit, BioNTech, more headline WCLC with next-gen lung cancer drugs”

/PRNewswire/ -- New results from the global Phase I/II ARROS-1 trial showed clinically meaningful activity with zidesamtinib in patients with advanced or... 14, 2026 /PRNewswire/ -- New results from the global Phase I/II ARROS-1 trial showed clinically meaningful activity with zidesamtinib in patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who had not previously received a tyrosine kinase inhibitor (TKI). Treatment-related adverse events led to dose reductions in 11% of patients and treatment discontinuation in 1%. "Zidesamtinib demonstrated clinically meaningful activity in TKI-naive patients with ROS1-positive NSCLC, with a safety profile consistent with previous reports and low rates of dose reduction and discontinuation. The findings support continued investigation of zidesamtinib in earlier lines of therapy," said Alexander Drilon, M.D., of Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York City. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. The global, single-arm, first-in-human ARROS-1 trial included a Phase II cohort of patients with locally advanced or metastatic ROS1-positive NSCLC who were naive to TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy was permitted.

Original title: “Zidesamtinib Demonstrates 93% Response Rate in TKI-Naive Patients With Advanced ROS1-Positive NSCLC”

New data shows nearly three‑year median overall survival

Original title: “Amivantamab regimen delivers longest survival in EGFR Ex20ins lung cancer”

The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.

Original title: “RevMed’s newly approved Rasonque could ‘hold up’ in non-small cell lung cancer”

A new data cut of a trial pitting ivonescimab, a bispecific antibody, against Merck’s Keytruda showed the new drug helped people live longer.

Original title: “Akeso, Summit cancer drug confirms lung cancer survival benefit”

Targeted RAS inhibition has demonstrated clinical benefit in patients with RAS G12C non-small cell lung cancer following initial treatment with chemotherapy and immunotherapy, but there are no targeted therapies for patients with other RAS tumor mutations. The rates of objective response, disease control and survival observed in patients treated with RASONQUE in this Phase 1/2 study support the ongoing global, randomized pivotal RASolve 301 trial ... Targeted RAS inhibition has demonstrated clinical benefit in patients with RAS G12C non-small cell lung cancer following initial treatment with chemotherapy and immunotherapy, but there are no targeted therapies for patients with other RAS tumor mutations. The rates of objective response, disease control and survival observed in patients treated with RASONQUE in this Phase 1/2 study support the ongoing global, randomized pivotal RASolve 301 trial evaluating RASONQUE in previously treated RAS mutant non-small lung cancer. The trial evaluated the safety and efficacy of once-daily doses of RASONQUE 300 mg or less in 136 patients with second-line or later NSCLC with tumors carrying diverse RAS mutations other than RAS G12C, and whose disease had progressed following, or who were intolerant to, platinum-based chemotherapy and anti-PD-(L)1 therapy. RASONQUE demonstrated dose-dependent antitumor activity and exhibited a manageable safety profile in the Phase 1/2 trial. Within the 160 mg to 220 mg dose group, a subgroup of 38 docetaxel-naïve patients had previously received first- or second-line platinum-based chemotherapy and anti-PD-(L)1 therapy. In this subgroup, the confirmed objective response rate was 42% (95% confidence interval [CI], 26%-59%) and a disease control rate of 89% (95% CI, 75%-97%). RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. IMPORTANT SAFETY INFORMATION FOR U.S. APPROVED INDICATION · RASONQUE is associated with the following Warnings and Precautions: Dermatologic and Soft Tissue Toxicity, Stomatitis and Oral Disorders, Diarrhea, Gastrointestinal Perforation, Interstitial Lung Disease (ILD)/Pneumonitis, and Embryo-Fetal Toxicity.

Original title: “New England Journal of Medicine Publishes Phase 1/2 Clinical Data on Revolution Medicines’ RASONQUE™ (daraxonrasib) in Metastatic Non-Small Cell Lung Cancer - BioSpace”

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy ... The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value. Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay. Targeted RAS inhibition has demonstrated clinical benefit in patients with RAS G12C non-small cell lung cancer following initial treatment with chemotherapy and immunotherapy, but there are no targeted therapies for patients with other RAS tumor mutations. The rates of objective response, disease control and survival observed in patients treated with RASONQUE in this Phase 1/2 study support the ongoing global, randomized pivotal RASolve 301 trial evaluating RASONQUE in previously treated RAS mutant non-small lung cancer. The 38-patient subgroup had median overall survival of 16.0 months; the global, randomized Phase 3 RASolve 301 trial in NSCLC is ongoing.

Original title: “An experimental lung cancer drug held disease in check for 89% of patients in one group.”

Daraxonrasib, an oral RAS inhibitor therapy, achieved durable responses in pretreated patients with RAS-mutant non-small cell lung cancer (NSCLC) in a Phase 1/2 trial led by The University of Texas MD Anderson Cancer Center. Chemotherapy with docetaxel remains a common standard treatment option for patients with RAS-mutant NSCLC whose disease has progressed after platinum-based chemotherapy and immunotherapy. Historical studies in this setting have reported response rates of 9 to 14%, median progression-free survival (PFS) of 3 to 4.5 months, and median overall survival (OS) of approximately 9 to 12 months. This highlights a significant need for new treatment options for these patients. How effective was daraxonrasib in this lung cancer trial? The most clinically relevant results were observed in 38 patients with NSCLC treated with 160-220 mg. The study, published today in The New England Journal of Medicine, was led by David Hong, M.D., deputy chair of Investigational Cancer Therapeutics. “Immunotherapy has improved outcomes for many patients with non-small cell lung cancer, but the majority of these cancers eventually progress,” Hong said. “At that point, the few treatment options available to these patients often have modest clinical benefit and substantial toxicities, so these early results are encouraging.” This trial was funded by Revolution Medicines. A full list of collaborating authors and their disclosures can be found with the full paper in The New England Journal of Medicine. Immunotherapy has improved outcomes for many patients with non-small cell lung cancer, but the majority of these cancers eventually progress. At that point, the few treatment options available to these patients often have modest clinical benefit and substantial toxicities, so these early results are encouraging. At the recommended Phase 3 dose, 51% of patients experienced an adverse effect at grade 3 or higher, with 71% experiencing dose modifications and 10% having to discontinue treatment. The most common adverse effects were rash, which occurred in 90% of patients (8% grade 3 or above) and gastrointestinal issues, including diarrhea, nausea and vomiting (73%, 62% and 54% respectively overall, each less than 10% grade 3 or above). What are the next steps for daraxonrasib in lung cancer? The initial data from this trial, which were presented at the 2025 European Lung Congress, prompted the Phase 3 trial now underway.

Original title: “Daraxonrasib demonstrates initial antitumor activity in RAS-mutant lung cancer | UT MD Anderson”

co occurring egfr l858r mutation and her2 amplification in nsclc identified by stepwise molecular profiling

Original title: “Co-Occurring EGFR L858R Mutation and HER2 Amplification in NSCLC Identified by Stepwise Molecular Profiling.”

pole p286r mutated hepatoid adenocarcinoma of the lung showing substantial response to immune checkpoint inhibition

Original title: “A POLE P286R-Mutated Hepatoid Adenocarcinoma of the Lung Showing Substantial Response to Immune Checkpoint Inhibition.”

sixty years of lung cancer screening from sputum cytology to low dose ct and the emerging precision era

Original title: “Sixty Years of Lung Cancer Screening: From Sputum Cytology to Low-Dose CT and the Emerging Precision Era.”

targeting egfr in lung cancer lessons in signal transduction and treatment induced mutagenesis

Original title: “Targeting EGFR in lung cancer: lessons in signal transduction and treatment-induced mutagenesis.”

reappraisal of endobronchial polypoid adenocarcinoma of the lung a clinicopathological analysis of 11 cases

Original title: “Reappraisal of Endobronchial Polypoid Adenocarcinoma of the Lung: A Clinicopathological Analysis of 11 Cases.”

squamous cell carcinoma of the lung presenting as paraneoplastic antibody positive orbital myositis with review of literature

Original title: “Squamous cell carcinoma of the lung presenting as paraneoplastic antibody positive orbital myositis with review of literature.”

Radiopharm Theranostics is a clinical ... and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and five Phase 1 trials in a variety ... Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and five Phase 1 trials in a variety of solid tumor cancers including lung, breast, prostate and brain. 20, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 180mCi in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positi Advancing RAD202 Phase 1 trial to next dose level of 180mCi in patients with HER2+ advanced solid tumors · Previous diagnostic study of RAD202 in ten HER2-positive breast cancer patients demonstrated clinical proof-of-concept with positive safety and biodistribution As we execute on our clinical development strategy, we remain focused on unlocking the full potential of RAD202 and generating meaningful data that could support a differentiated radiotherapeutic option for HER2-positive patients in need of new treatment alternatives.”

Original title: “Radiopharm Theranostics Receives Positive Recommendation from Data Safety and Monitoring Committee to Advance to Cohort 4 in 177Lu-RAD202 Phase 1 HEAT Clinical Trial - BioSpace”

Saffron trial delivers positive results

Original title: “Orpathys plus Tagrisso shows survival benefit in lung cancer”

A combination of AstraZeneca’s Tagrisso and Hutchmed’s Orpathys extended survival for some lung cancer patients. Elsewhere, MapLight floated the idea of partnering on its autism drug.

Original title: “AstraZeneca scores in lung cancer; Sandoz inks a China deal”

AstraZeneca will push through with its other Phase 3 studies for volrustomig, including in cervical cancer and mesothelioma.

Original title: “AstraZeneca pulls plug on late-stage lung cancer trial, taking another clinical blow”