On October 1, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported the initiation of a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for zipalertinib in combination with platinum-based chemotherapy for the treatment of patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations under the FDA’s Real-Time Oncology Review (RTOR) program.

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The RTOR program allows sponsors to submit clinical data in advance of the complete application to facilitate earlier review of efficacy and safety results. Completion of the NDA submission is expected by year-end 2026.

The NDA submission is based on data from the Phase 3 REZILIENT3 trial, which met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival for zipalertinib plus chemotherapy compared to chemotherapy alone. These results were recently presented at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC) during a Presidential Symposium, where potentially practice-changing clinical data are highlighted.

Zipalertinib holds FDA Breakthrough Therapy designation for the treatment of patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapy. An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.

Cullinan Therapeutics is eligible to receive $30 million and $100 million in milestone payments upon second-line and first-line U.S. regulatory approvals, respectively.

About Zipalertinib

Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About EGFR Exon 20 Insertion Mutations

NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,1 with insertions at exon 20 accounting for up to 12% of these mutations.

(Press release, Cullinan Oncology, OCT 1, 2026, View Source [SID1234671232])

On October 1, 2026 Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported that the companies have entered into a global license, development, and commercialization agreement for up to six potential biosimilar candidates, with two confirmed investigational biosimilar candidates, SB41, a biosimilar candidate referencing Fasenra1 (benralizumab), and SB44, a biosimilar candidate referencing Ilaris2 (canakinumab).

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Under the terms of the agreement, Samsung Bioepis will be responsible for the development, regulatory registration, and manufacture of the biosimilars, while Teva will be responsible for commercialization in global markets, including the United States (U.S.), Europe, and Canada. The companies have agreed to an option for expanding the partnership to other territories.

This agreement reinforces the long-standing and successful partnership between Samsung Bioepis and Teva, which has already resulted in the successful commercialization of EPYSQLI (eculizumab-aagh) in the U.S. The companies have also expanded that agreement further to include OPUVIZ (aflibercept) in Canada. The expanded collaboration reflects a shared approach to combining complementary capabilities for broadening access to biosimilar medicines across global markets.

"We are thrilled to expand our successful partnership with Teva with these new biosimilar candidates. This agreement marks another milestone in our shared journey to improve patient access to life-changing medicines," said Kyung-Ah Kim, President and Chief Executive Officer at Samsung Bioepis. "At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world."

Richard Francis, President and CEO of Teva said, "Biosimilars are an increasingly important part of our Pivot to Growth strategy and our ambition to transform into a leading biopharmaceutical company. This global multi-product agreement is a significant step in scaling our biosimilars business, adding greater breadth to our pipeline and building on the strong foundation we have established with Samsung Bioepis in the U.S. By combining a strong and growing portfolio and our excellent global commercial capabilities, we are strengthening our leadership position in biosimilars and our ability to bring more treatment options to patients around the world."

(Press release, Teva, OCT 1, 2026, View Source [SID1234671231])

On October 1, 2026 Tempus AI, Inc. (NASDAQ: TEM) reported that 13 abstracts have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23–27 in Madrid.

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At this year’s congress, Tempus will showcase clinical research revealing insights in cancer biology, treatment response and patient outcomes across solid tumors, including prostate, breast, non-small cell lung cancer (NSCLC), renal cell carcinoma and gynecologic malignancies. In addition to scientific presentations, Tempus will highlight its AI-enabled technology and product offerings, including Tempus Lens, Tempus One, and its foundation models, at booths #1068 & #1069.

"Across 13 abstracts at ESMO (Free ESMO Whitepaper), researchers are using Tempus’ real-world multimodal data to identify clinically meaningful differences in cancer biology, treatment response and patient outcomes," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "By connecting molecular data with clinical histories and outcomes, these studies are generating insights that can inform biomarker development, patient stratification and clinical trial design, helping to advance precision oncology research."

Friday, October 23; 15:15 – 16:00 CET

Clinicogenomic differences between early-onset (EO-PCa) and average-onset prostate cancer (AO-PCa): A retrospective cohort study

Presentation Number: 2256P
Context-dependent prognostic impact of PTEN alterations (alt) in patients with metastatic androgen pathway modulation sensitive (mAPMS) prostate cancer

Presentation Number: 2279P
De novo vs metachronous metastatic prostate cancer (mPC): A comprehensive clinicogenomic analysis

Presentation Number: 2225P
Genomic characterization and prognostic impact of the TP53-Y220C mutation across solid tumors in real-world data

Presentation Number: 4461P
Genomic landscape in early-onset breast cancer: A comprehensive analysis from the Tempus database

Presentation Number: 4307P
Real-world implementation of large-panel ctDNA NGS testing in metastatic NSCLC and colorectal cancer: interim results of the multicenter LOLA Project

Presentation Number: 3283P
Sunday, October 25; 12:00 – 12:45 CET

Novel immune archetypes stratify overall survival and refine the prognostic landscape in head and neck squamous cell carcinoma

Presentation Number: 359P
A comprehensive AI-enabled pre-screening panel for non-small cell lung carcinoma (NSCLC) using computational pathology applied to H&E whole slide images (WSI)

Presentation Number: 320P
Monday, October 26; 12:00 – 12:45 CET

Landscape of somatic alterations and real-world outcomes of ovarian cancer associated with ATM mutations

Presentation Number: 1323P
Real-world impact of vascular endothelial growth factor (VEGF) on (chemo)immunotherapy (IO) response in non-small cell lung cancer (NSCLC)

Presentation Number: 2704P
Real-world outcomes of trastuzumab deruxtecan (T-DXd) in patients with advanced gynecologic malignancies

Presentation Number: 1319P
E-Posters

Higher GCN2 expression is associated with favorable clinical and genomic features in advanced prostate cancer

Presentation Number: 2306eP
GCN2 RNA expression identifies a distinct immunologically cold and genomically favorable phenotype in advanced renal cell carcinoma

Presentation Number: 3644eP
Learn more about Tempus at ESMO (Free ESMO Whitepaper) Congress 2026 here.

(Press release, Tempus, OCT 1, 2026, View Source [SID1234671230])

On October 1, 2026 BostonGene, developer of the leading AI model for tumor and immune biology, reported that Nathan Fowler, MD, Chief Medical Officer, will participate in the 2nd Annual Global Cancer Research & Innovation Symposium, taking place October 5–6, 2026, in New York City. Dr. Fowler will join leaders from across the oncology ecosystem for a discussion on how multimodal data can be integrated to improve drug discovery and clinical development.

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As oncology therapies become more precise, development teams increasingly need to understand how genomic alterations, tumor states, and immune biology interact within individual patients. The panel, titled "Multi-Omics: One Size Does Not Fit All!," will examine how whole genome sequencing, single-cell analysis, spatial transcriptomics, and other advanced modalities can be combined to explain therapeutic response and resistance, identify biologically defined patient populations, and guide trial design and therapeutic strategy.

"The objective is not simply to generate more data. It is to understand why a therapy works in one patient and not another, and then translate that biology into decisions that improve clinical development," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "By placing each patient and drug into a broader biological context, we can identify mechanisms of response and resistance, define the patients most likely to benefit, and help development teams make better decisions about biomarkers, trial design, and therapeutic strategy. I look forward to discussing how these capabilities can help move precision oncology from biological insight to clinical action."

Session Details:

Title: Multi-Omics: One Size Does Not Fit All!
Moderator:
Stan Skrzypczak, MS, MBA, Managing Partner, 5 Prime Life Science Consulting
Featured Panelists:
Nathan Fowler, MD, Chief Medical Officer, BostonGene
Serge Saxonov, PhD, CEO and Co-Founder, 10x Genomics
Elli Papaemmanuil, PhD, Global Vice President, Oncology, Translational Medicine, Genentech
Prathesh Sathyan, PhD, Head of AMR Oncology and Medical Affairs, Illumina
For more information on the conference or to view the full agenda, visit avbcc.org/gcris.

(Press release, BostonGene, OCT 1, 2026, View Source [SID1234671229])

On October 1, 2026 Novocure (Nasdaq: NVCR) reported that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Optune Pax for the treatment of adult patients diagnosed with unresectable locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel.

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"The approval of Optune Pax provides a promising new treatment option for locally advanced pancreatic cancer, a disease with an urgent need for effective therapies," said Makoto Ueno, MD, PhD, Director, Department of Gastroenterology, Kanagawa Cancer Center, Yokohama. "In the Phase 3 PANOVA-3 trial for Optune Pax, there was a statistically significant improvement in overall survival and pain progression was delayed, helping to preserve overall quality of life for people with this disease."

Optune Pax is a portable medical device that delivers Tumor Treating Fields (TTFields) non-invasively through wearable arrays. TTFields are alternating electric fields that disrupt processes critical for cancer cell division and survival, resulting in cancer cell death without significantly affecting healthy cells.

"The approval of Optune Pax by the Ministry of Health, Labour and Welfare is an important milestone for Novocure in our efforts to improve outcomes for some of the most challenging and aggressive cancers, including advanced pancreatic cancer," said Hidehito Kotani, Senior Vice President, Head of Asia Pacific, Novocure. "Optune Pax is a fundamentally different treatment for solid tumor cancers and we look forward to bringing this option to healthcare providers and people living with locally advanced pancreatic cancer."

The MHLW approval of Optune Pax was based on the positive results of the Phase 3 PANOVA-3 trial.

The PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (gem/nab-pac) as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma, compared to gem/nab-pac alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields.

In PANOVA-3, Optune Pax was well-tolerated and did not exacerbate gem/nab-pac -related systemic toxicity, no new safety signals were observed, and serious adverse events (SAEs) were comparable between study arms. Most Optune Pax-treated patients experienced the expected device-related skin adverse events (AEs) under the arrays (76.3% of the Optune Pax-treated participants). The majority of these events were mild to moderate (Grade 1-2), with 21 (7.7%) experiencing a Grade ≥3 event.

The results from the Phase 3 PANOVA-3 trial were published in the Journal of Clinical Oncology, available online at View Source

Optune Pax was approved by the U.S. Food and Drug Administration in February 2026 and received a CE Mark in June 2026.

Pancreatic Cancer

According to the World Health Organization (WHO), pancreatic cancer is one of the most lethal cancers and is the fourth most frequent cause of death from cancer in Japan.1 While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing.2 It is estimated that in Japan approximately 46,000 patients are diagnosed with pancreatic cancer each year,3 with a five-year relative survival rate of just 12%.4

Physicians use different combinations of surgery, radiation, and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. Unfortunately, most locally advanced pancreatic cancer cases are diagnosed when the cancer is no longer operable, meaning encasement of blood vessels, but no extra-pancreatic disease, leaving few treatment options. The standard of care for locally advanced pancreatic cancer is chemotherapy with or without radiation, and surgery if it is possible.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi-mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and it demonstrated enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit novocure.com/ttfields.

(Press release, NovoCure, OCT 1, 2026, View Source [SID1234671228])