On October 7, 2026 Tempus (NASDAQ: TEM) reported an expanded, multi-year collaboration to support the potential commercialization of intismeran autogene (V940/mRNA-4157), a novel, potential first-in-class individualized neoantigen therapy (INT) being evaluated in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with completely resected stage IIB-IV melanoma and other cancer types. Intismeran autogene is jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada. The collaboration builds on joint efforts initiated last year and will support preparations for the potential commercialization of intismeran autogene.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of the collaboration, Tempus will manage the timely collection and transfer of tumor tissue and blood samples required for next-generation sequencing (NGS). Subject to applicable regulatory approvals, Tempus will also provide NGS services to support the intismeran autogene design and manufacturing process. Financial terms of the collaboration were not disclosed.

"Bringing an individualized therapy like intismeran autogene from clinical development toward potential commercialization requires a seamless, highly reliable diagnostic network," said Said Francis, Moderna’s Chief Business Officer and General Manager, Individualized Neoantigen Therapies. "Working with Tempus allows us to leverage their commercial footprint and advanced sequencing capabilities as we work to deliver individualized neoantigen therapies to patients at scale."

"What makes individualized neoantigen therapies so exciting is that every treatment is designed around the biology of an individual patient’s tumor. That requires a carefully coordinated end-to-end process, from collecting a patient’s tumor sample and generating sequencing data to designing and manufacturing an individualized therapy," said Jannie Oosthuizen, President, Global Oncology and MSD International. "Collaborations like this one with Tempus are helping build the infrastructure needed to bring this innovative approach to patients."

"Individualized therapies represent the future of precision medicine, but delivering on their promise requires an end-to-end clinical workflow that works in the real world," said Eric Lefkofsky, founder and CEO of Tempus. "By combining our operational scale and deep clinical integration with Merck and Moderna’s mRNA innovation, we are building the infrastructure needed to bring individualized cancer vaccines to patients."

(Press release, Tempus, OCT 7, 2026, View Source [SID1234673266])

On October 7, 2026 Pfizer Inc. (NYSE: PFE) reported that the U.S. Food and Drug Administration (FDA) has approved TUKYSA (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive (HER2+) breast cancer following induction treatment. The approval expands the use of TUKYSA to frontline, an earlier stage of metastatic disease, offering a new chemotherapy-free maintenance treatment option that may help further delay disease progression.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Since its first approval in 2020, TUKYSA has become an important treatment for patients with second-line HER2+ metastatic breast cancer. Today’s FDA approval marks the next chapter for TUKYSA, bringing it into the front-line maintenance setting and offering patients a chemotherapy-free option that can help delay disease progression after initial treatment. This approval reflects Pfizer’s commitment to advancing therapies across the breast cancer treatment journey and delivering meaningful new options for people living with metastatic breast cancer."

– Aamir Malik, Executive Vice President, Chief U.S. Commercial Officer, Pfizer

"The treatment landscape for HER2+ metastatic breast cancer has evolved dramatically over the past decade, but many patients still experience disease progression despite initial benefit from therapy. The HER2CLIMB-05 findings support TUKYSA plus trastuzumab and pertuzumab as a chemotherapy-free maintenance strategy that allows us to target HER2-positive tumors from multiple angles and can help prolong disease control."

– Erika Hamilton, M.D., principal investigator of HER2CLIMB-05 and Chief Development Officer, Late Phase & Director, Breast Cancer Research for Sarah Cannon Research Institute (SCRI)

Key Results from the HER2CLIMB-05 Phase 3 Trial

Prolonged Median Progression-Free Survival (PFS): The primary endpoint analysis showed a 35.9% reduction in the risk of disease progression or death among patients treated with TUKYSA, trastuzumab, and pertuzumab compared to those treated with placebo, trastuzumab, and pertuzumab, following induction treatment, as assessed by the investigator (hazard ratio of 0.64, 95% confidence interval (CI): 0.51-0.80; 2-sided p<0.0001). Median investigator-assessed PFS for patients in the TUKYSA arm was 24.9 months (95% CI, 21.3-not reached) compared to 16.3 months (95% CI, 12.6-18.7) in the placebo arm, representing a difference of 8.6 more months that patients lived without their cancer worsening.
Safety Profile: The safety and tolerability of TUKYSA was generally consistent with its known safety profile, with the exception of increased severity of hepatotoxicity. The majority of hepatotoxicity events were generally asymptomatic and reversible with dose modification and/or discontinuation. The most commonly reported adverse events (≥20%) were diarrhea, musculoskeletal pain, hepatotoxicity, nausea, fatigue, rash, and vomiting. Serious adverse reactions in ≥1% of patients included hepatotoxicity (3.9%), including one patient who experienced a fatal adverse reaction of drug-induced liver injury.
Published Previously: Results from HER2CLIMB-05 were published in the Journal of Clinical Oncology and presented at the 2025 San Antonio Breast Cancer Symposium (SABCS).
About the Phase 3 HER2CLIMB-05 Trial

The HER2CLIMB-05 trial is a randomized, double blind, placebo-controlled, pivotal Phase 3 study evaluating the efficacy and safety of TUKYSA compared to placebo, both in combination with trastuzumab and pertuzumab, as maintenance therapy for patients with HER2+ metastatic breast cancer (MBC) following induction therapy in the front-line setting.
HER2 is overexpressed in up to 15-20% of breast cancers and is associated with poor prognosis, with an estimated five-year survival rate of 41% to 47%, depending on hormone receptor status.1-3
Trial participants who completed induction therapy of trastuzumab, pertuzumab, and a taxane, with no evidence of progression, were randomized to receive TUKYSA in combination with trastuzumab plus pertuzumab (n=326) or placebo in combination with trastuzumab plus pertuzumab (n=328).
The primary endpoint is PFS as assessed by the investigator. Overall survival is a key secondary endpoint.
Continuing Pfizer’s Legacy of Leadership in Breast Cancer
Pfizer has been a leader in breast cancer for over 25 years, and today we have five medicines and one biosimilar approved to treat different subtypes of the disease, reaching over 4.9 million patients worldwide.

In the U.S., TUKYSA is already a National Comprehensive Cancer Network (NCCN) Category 1 second-line plus treatment for HER2+ MBC patients. This approval extends the reach of TUKYSA as part of a front-line maintenance regimen, bringing patients a new option to delay disease progression without the need for continued chemotherapy and helping physicians further individualize treatment plans to best meet the needs of each unique patient.

About TUKYSA (tucatinib)
TUKYSA (tucatinib) is an orally administered tyrosine kinase inhibitor of HER2. TUKYSA is approved in combination with trastuzumab and pertuzumab for the maintenance treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment. TUKYSA has also been approved in combination with trastuzumab and capecitabine to treat adults with HER2-positive advanced unresectable or MBC, including patients with brain metastases who have received one or more prior anti-HER2 breast cancer treatments in the metastatic setting.

The full U.S. Prescribing Information for TUKYSA can be found here. There may be a delay as the document is updated with the latest information. It will be available as soon as possible. Please check back for the updated full information shortly.

(Press release, Pfizer, OCT 7, 2026, View Source [SID1234673265])

On October 7, 2026 OncoBayes, a privately held clinical-stage pharmaceutical company, reported the successful completion of preclinical work with OB-001, demonstrating the product’s potential to tackle two major unmet needs in oncology: ADC resistance and the brain penetration of tyrosine kinase inhibitors (TKIs).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

OB-001 is a highly selective and effective inhibitor of two key efflux pumps (P-gp and BCRP), which are present both on the blood-brain barrier and on tumour cells. The product is being developed as a once-daily oral tablet, which will be used in combination with a number of gold standard oncology treatments in order to optimise their efficacy.

In perfused-brain mouse studies, OB-001 pretreatment significantly raised brain exposure of four gold standard kinase inhibitors – whilst systemic (plasma) exposure remained broadly unchanged. Data presented at AACR (Free AACR Whitepaper) 2026 demonstrated that OB-001 could increase the brain exposure of osimertinib by almost 400% with minimal systemic changes[1],[2]. Based on a translational PK-PD-TGI model for osimertinib, this increase is projected to deliver a step-change in CNS progression-free survival for EGFRm NSCLC patients. The improved control of brain metastases is still a major area of unmet need in NSCLC and breast cancer.

The same efflux pumps have also been identified as a key resistance mechanism impacting ADCs – with the over-expression of these pumps leading to reduced payload concentrations in the tumour. Preclinical work using a bidirectional transporter assay demonstrated that OB-001 reduces efflux for several leading payloads, including SN-38 (e.g. sacituzumab govitecan, Trodelvy), DM4 (e.g. mirvetuximab soravtansine, Elahere) and DXd (e.g. trastuzumab deruxtecan, Enhertu).

Plans are currently underway to move into a parallel clinical trial programme to generate POC data in combination with osimertinib, and also evaluate T-DXd re-sensitisation.

"This is a critical milestone for our team, and we are now well positioned to initiate our clinical plans with OB-001" said Jim Millen, Chief Executive Officer for OncoBayes. "OB-001 is on track to become a first-in-class drug with broad potential as a simple, oral adjunct to a range of blockbuster oncology therapies. This is truly a pipeline in a product opportunity."

(Press release, OncoBayes, OCT 7, 2026, View Source [SID1234673264])

On October 7, 2026 MimiVax Inc., a clinical-stage biotechnology company dedicated to the development of innovative cancer immunotherapies, in collaboration with Roswell Park Comprehensive Cancer Center, reported results from the SURVIVE trial (NCT05163080), the Company’s Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating its novel cancer vaccine, SurVaxM, in patients with newly diagnosed glioblastoma.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The data reflect the first reportable results from the fully enrolled clinical trial, which has been underway since 2022 at 11 U.S. cancer centers.

Across all 233 evaluable patients, SurVaxM improved median overall survival (OS), the primary endpoint, to 22.8 months versus 20.3 months for placebo (hazard ratio [HR] 0.75; 95% CI 0.54 to 1.03; log-rank p=0.076 adjusted for MGMT & KPS stratification), a clinically meaningful result that did not quite reach the traditional threshold for statistical significance (p=0.05).

Importantly, among a prespecified key subpopulation of patients aged 65 and under, SurVaxM demonstrated a statistically significant benefit, with median OS of 24.2 months versus 20.2 months (HR 0.64; 95% CI 0.44 to 0.93; p=0.019 adjusted for MGMT & KPS stratification). A significant benefit was seen in progression-free survival (PFS) in the same subgroup of patients 65 and under (HR 0.64; p=0.018), including improvement in progression-free survival at 12 months (44% SurVaxM vs 24% placebo).

"Every patient with glioblastoma is facing one of the hardest diagnoses in medicine. To see many of our study patients living longer, and several of them living years longer, is deeply meaningful to every one of us who has participated in the work to develop and study this new treatment approach," said Ajay Abad, M.D., study principal investigator and Assistant Professor of Oncology and Neurology in the Department of Neuro-Oncology at Roswell Park. "In a disease where we’ve had limited progress over the last 20 years, an improvement in survival of this magnitude is noteworthy."

Robert Fenstermaker M.D., co-principal investigator of the SURVIVE trial, Chair Emeritus of Neurosurgery at Roswell Park and Chief Medical Officer and Co-founder of MimiVax, added, "For patients 65 and under, this is one of the strongest signals we have seen in newly diagnosed glioblastoma in a long time. We designed the trial to provide a good comparison to our earlier Phase 2a study, while adding a placebo arm to account for improvements in standard of care that may have occurred over time. In a disease where progress has often been measured in weeks, results like these can be enormously meaningful."

Long-Term Survival

The new analysis also shows that approximately 42% of SurVaxM-treated patients 65 and under were alive through 30 months or longer, with no further deaths reported at 30 through 54 months. This durable, long-term survival represents a doubling of survival compared to placebo (42% SurVaxM vs. 18% Placebo). This level of long-term survival is uncommon in people with newly diagnosed glioblastoma and warrants continued follow-up and investigation.

"These initial results from the SURVIVE trial give us a clear and coherent picture. SurVaxM showed a consistent survival signal, with a substantial group of patients living well past what we typically see in this disease," said Michael Ciesielski, Ph.D., Chief Executive Officer and Co-Founder of MimiVax. "We believe these data make a compelling case for SurVaxM, and we look forward to discussing these robust findings with the FDA."

The Control Arm’s Strong Results

The placebo arm in SURVIVE outperformed the trial’s design assumptions, with a median overall survival of 20.3 months versus an expected 16-month historical benchmark. The contemporary standard of care performed better than historical references would have predicted, raising the bar against which SurVaxM was measured. The longer survival in the control arm made a statistically significant separation in the overall population more difficult to achieve and provides important context for interpreting the primary endpoint.

Safety

SurVaxM was well tolerated. Observed responses were predominantly Grade 1 or 2 injection-site reactions (injection-site reaction 48%, pain 41%, erythema 39%, pruritus 38%, swelling 29%) and influenza-like illness (13%). Rates of Grade 3 or higher adverse events were similar between arms (48% with SurVaxM versus 46% with placebo), as were overall serious adverse event rates (25% versus 21%). Adverse events led to treatment discontinuation in 4% of SurVaxM patients, with one discontinuation attributed to study treatment. There were no treatment-related deaths in either arm.

Regulatory Next Steps

MimiVax plans to request a meeting with the U.S. Food and Drug Administration in the coming months to review the SURVIVE data and align on the path forward for SurVaxM in newly diagnosed glioblastoma.

"We want to discuss Breakthrough Therapy Designation with the FDA, along with other expedited pathways, including accelerated approval," said Dr. Ciesielski. "The path to making SurVaxM available to patients will be determined in consultation with the agency."

A Serious Unmet Need

Glioblastoma is a deadly disease that strikes about 15,000 Americans every year. With few effective therapies and a standard of care that has not changed in more than 20 years, patients and families are desperate for new options.

About the SURVIVE Trial

SURVIVE (NCT05163080) is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating SurVaxM in combination with standard of care in patients with newly diagnosed glioblastoma. The fully enrolled trial included 233 evaluable patients at 11 leading U.S. cancer centers. The primary endpoint was overall survival (OS), with patients aged 65 and under prespecified as a key subpopulation for the primary endpoint. Secondary endpoints included progression-free survival (PFS), landmark survival, safety, and survivin-specific immune responses.

About SurVaxM

SurVaxM is a first-in-class, patented peptide-mimic immunotherapeutic vaccine that targets survivin, a cell-survival protein present in approximately 95% of glioblastomas and many other cancers. Delivered by subcutaneous injection, SurVaxM is designed to stimulate the patient’s own immune system to recognize and attack survivin-expressing cancer cells, with the goal of controlling tumor growth and preventing recurrence. SurVaxM holds FDA Orphan and Fast Track Designations for newly diagnosed glioblastoma and is being evaluated across multiple cancer indications, including glioblastoma, neuroendocrine tumors, multiple myeloma, and pediatric brain cancers. SurVaxM is for investigational use only and has not yet been approved by the FDA or any other regulatory authority for any indication.

The late-stage SURVIVE study for glioblastoma has completed enrollment and is no longer open to additional patients. There are no SurVaxM studies currently enrolling for glioblastoma.

(Press release, MimiVax, OCT 7, 2026, View Source [SID1234673263])

On October 7, 2026 AbbVie (NYSE: ABBV) reported that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Temab-A has received two BTDs: one in combination with bevacizumab for adults with refractory, metastatic CRC who have been previously treated with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody (mAb), and if indicated, anti-EGFR mAb therapy. The second designation is for Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC who have previously received treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy. These designations were primarily based on results from the first-in-human study M21-404 (NCT05029882).

"These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors," said Eleni Lagkadinou, M.D., Ph.D., vice president, oncology early development, AbbVie. "As one of the most advanced assets in our next-generation ADC portfolio, Temab-A has demonstrated potential across multiple tumor types, both as a monotherapy and in combinations. We believe these designations further support our strategy of advancing biomarker-driven therapies and underscore our commitment to developing transformative medicines for patients with difficult-to-treat cancers."

Colorectal and lung cancer together affect more than four million people worldwide each year and remain among the leading causes of cancer-related mortality.1,2 Despite advances in treatment, many patients with CRC and advanced NSCLC continue to experience disease progression, underscoring the need for new therapeutic approaches. The FDA’s BTD program is intended to expedite the development and review of investigational medicines with clinical evidence that may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Temab-A is an investigational asset and has not been approved for use by global regulatory authorities.

About Telisotuzumab Adizutecan (Temab-A)

Telisotuzumab adizutecan (Temab-A) is a next-generation, c-Met protein-targeting antibody-drug conjugate (ADC) with a topoisomerase 1 inhibitor (Top1i) payload being investigated in advanced solid tumors including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). The c-Met protein (also known as MET protein), with increased expression in many solid tumors, may contribute to disease progression and treatment resistance, reinforcing its potential as a promising therapeutic target.

Developed using AbbVie’s adizutecan platform, Temab-A combines a validated, humanized bivalent IgG1 monoclonal antibody that binds with high affinity to the c-Met protein with the Top1i payload through a cleavable valine-alanine linker and stable bromoacetamide attachment. This design is intended to support targeted delivery while minimizing systemic payload release.

In addition to CRC and NSCLC, Temab-A is being evaluated across other multiple advanced solid tumors, including head and neck squamous cell carcinoma (HNSCC), gastroesophageal adenocarcinoma (GEA), pancreatic ductal adenocarcinoma (PDAC), and ovarian cancer (OC). The clinical development program includes multiple Phase 3 and Phase 2/3 studies evaluating Temab-A as both a monotherapy and in combination with other therapies across a range of treatment settings. Additional information about ongoing Temab-A clinical trials can be found on clinicaltrials.gov.

(Press release, AbbVie, OCT 7, 2026, View Source [SID1234673262])