On October 19, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present new clinical data from its late-stage oncology pipeline with 16 abstracts spanning the Company’s tumor focus areas, including lung and breast cancer, at the European Society for Medical Oncology ("ESMO") 2026 Congress held in Madrid, Spain, from October 23–27, 2026.

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Key oral presentations will focus on clinical data for pumitamig (BNT327/BMS986545), a PD-L1×VEGF-A bispecific immunomodulator being jointly developed with Bristol Myers Squibb ("BMS"), plus docetaxel in second-line metastatic non-small cell lung cancer ("NSCLC") as well as pumitamig in combination with elfetabart drozuntecan (elfe-D or BNT324/DB-1311), a B7-H3-targeting antibody-drug conjugate ("ADC") being jointly developed with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"), across several advanced solid tumors – complementing the data in lung cancer presented earlier this year. This new clinical data advances BioNTech’s differentiated novel-novel combination approach. Additional presentations for pumitamig and ADCs reflect BioNTech’s tumor-focused strategy aimed at addressing significant unmet medical needs across various stages of disease.

"Sixteen abstracts spanning ten tumor types – this is our significant data presence at this year’s ESMO (Free ESMO Whitepaper). It demonstrates momentum for our late-stage oncology pipeline across strategic key assets and tumor areas such as lung and breast cancer," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "For our PD-L1xVEGF immunomodulator pumitamig, we will be sharing new data that highlights its pan-tumor potential, including in challenging treatment settings where patients still show limited benefit from current standard of care therapies. Our goal is to establish pumitamig as a potential backbone for future combination regimens across multiple tumor types, including novel-novel treatment combinations. At this year’s conference, we will showcase the potential of this approach in two presentations featuring ADC combinations, aimed to further enhance outcomes for patients."

Highlights from BioNTech’s presentations at ESMO (Free ESMO Whitepaper) 2026:

Pumitamig – an investigational PD-L1×VEGF-A bispecific immunomodulator:
●NSCLC: First data from the global ROSETTA Lung-107 Phase 2 clinical trial (NCT06841055) evaluating pumitamig plus docetaxel in patients with metastatic NSCLC whose disease progressed after immunotherapy plus chemotherapy will be presented in a late-breaking oral presentation. This clinical trial extends evidence for pumitamig’s non-small cell lung cancer development program into the second-line setting where there remains high unmet medical need, representing the third global Phase 2 dataset in lung cancer.
●SCLC and TNBC with brain metastases: Results from a subgroup analysis of two Phase 2 clinical trials (NCT06449209; NCT06449222) evaluating pumitamig plus chemotherapy in patients with small cell lung cancer ("SCLC") or triple-negative breast cancer ("TNBC") showed systemic efficacy generally consistent in patients with and without brain metastases. These early data suggest intracranial efficacy and add to the clinical evidence for pumitamig plus chemotherapy in tumor types where brain metastases often occur and remain challenging to treat as many systemic therapies have limited ability to cross the blood-brain barrier.
●2L neuroendocrine neoplasms: First results from a Phase 2 clinical trial conducted in China (NCT05879055) evaluating pumitamig plus FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy in patients with unresectable neuroendocrine neoplasms after first-line platinum-based chemotherapy showed encouraging preliminary antitumor activity and a manageable safety profile. These data broaden the clinical evidence for pumitamig across diverse tumor types.

Novel-novel combination of pumitamig and elfetabart drozuntecan, an investigational B7-H3-targeted ADC:
●Advanced solid tumors: First results from the global Phase 2 clinical trial (NCT06953089) evaluating pumitamig in combination with elfetabart drozuntecan in patients with advanced solid tumors showed encouraging preliminary antitumor activity across multiple tumor types and a manageable safety profile, with minimal overlapping toxicities observed. These data support the potential of pumitamig as a backbone in novel treatment combinations, furthering BioNTech’s combination strategy across multiple tumor types with high unmet medical need.

BioNTech is advancing a diversified oncology pipeline spanning next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies, both as monotherapies and novel-novel combination approaches. With 13 ongoing Phase 3 trials as well as multiple novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of cancer treatment among the Company’s tumor focus areas from early- to late-stage conditions.

All abstracts are available through the ESMO (Free ESMO Whitepaper) website. Further information on BioNTech’s oncology pipeline can be accessed here.

Full presentation details:

Candidate
Abstract Title
Abstract Number/Presentation Details
Pumitamig
A global phase 2, open-label trial of pumitamig (PD-L1 × VEGF-A bsAb) + docetaxel post-chemoimmunotherapy in mNSCLC: First data from ROSETTA Lung-107
Abstract #LBA76
Rapid Oral Presentation
NSCLC, Metastatic
Oct 25, 2026: 8:30 – 10:00am CET
Efficacy of pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in patients with SCLC or TNBC with brain metastases: A subgroup analysis of two phase 2 trials
Abstract #1951RO
Rapid Oral Presentation
Investigational Immunotherapy
Oct 24, 2026: 8:30 – 10:00am CEST
First results from a phase 2 trial of second-line pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in unresectable neuroendocrine neoplasms
Abstract #2393O
Proffered Paper Presentation
NETs and Endocrine Tumours
Oct 26, 2026: 10:15 – 11:45am CET
ROSETTA RCC-208: A phase 1/2, open-label, randomized study of pumitamig alone or in combination with ipilimumab or cabozantinib in advanced renal cell carcinoma (RCC)
Abstract #3639TiP
Poster Presentation
Renal Cancer
Oct 23, 2026: 3:15 – 4:00pm CEST
ROSETTA Gastric-204: A randomized, phase 2/3 study of first-line (1L) pumitamig + chemotherapy versus nivolumab (NIVO) + chemotherapy in advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC), or esophageal adenocarcinoma (EAC)
Abstract #3081eTiP
ePoster Presentation
Oesophagogastric Cancer
Oct 23 – 27, 2026
A phase 1/2 trial of first-line pumitamig monotherapy or pumitamig plus ipilimumab in advanced or unresectable hepatocellular carcinoma (ROSETTA HCC-206)
Abstract #1762eTiP
ePoster Presentation
Hepatocellular Carcinoma
Oct 23 – 27, 2026
Pumitamig + elfetabart drozuntecan
Elfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) + pumitamig (PD-L1 x VEGF-A bsAb) in patients with advanced solid tumors: First results from a global phase 2 trial
Abstract #999O
Proffered Paper Presentation
Developmental Therapeutics
Oct 24, 2026: 2:45 – 4:15pm CEST
Pumitamig + trastuzumab pamirtecan
Pumitamig + trastuzumab pamirtecan (T-Pam) in patients (pts) with HR+, HER2-low advanced/metastatic breast cancer (a/mBC): Phase 1 results of a phase 1/2, open-label trial (BNT323-03)
Abstract #1777P
Poster Presentation
HER2+ Breast Cancer
Oct 24, 2026: 12:00 – 12:45pm CEST

Elfetabart drozuntecan
Elfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) in patients with platinum-resistant ovarian cancer (PROC): Efficacy and safety data from a Phase 2 dose optimization cohort
Abstract #1255P
Poster Presentation
Gynaecological Cancers
Oct 26, 2026: 12:00 – 12:45pm CET
BNT324-03: A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate (ADC), with docetaxel as treatment of patients (pts) with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC)
Abstract #2300TiP
Poster Presentation
Metastatic Prostate Cancer
Oct 23, 2026: 3:15 – 4:00pm CEST
Gotistobart
Gotistobart plus pembrolizumab demonstrates durable antitumor activity in advanced melanoma refractory or resistant to both prior anti-CTLA-4 and anti-PD-(L)1 therapies
Abstract #2106P
Poster Presentation
Melanoma
Oct 24, 2026: 12:00 – 12:45 pm CEST
BNT317
BNT317: An anti–PD-1 × CD39 bispecific antibody demonstrating preclinical antitumor activity
Abstract #420P
Poster Presentation
Basic Science
Oct 23, 2026: 3:15 – 4pm CEST
Beruzatatug pelitecan (YL202/BNT326)
Clinical outcomes of YL202/BNT326 (HER3 ADC) in advanced/metastatic HR+/HER2-null/low breast cancer (BC) in chemotherapy (chemo)-naïve and exposed patients (pts)
Abstract #1881P
Poster Presentation
HR+ Breast Cancer
Oct 24, 2026: 12:00 – 12:45pm CEST
BNT329
A first-in-human phase 1/2 dose-escalation and expansion trial of BNT329 (an anti-carbohydrate antigen 19-9 antibody-drug conjugate [CA19-9 ADC]) in patients (pts) with advanced solid tumors that express CA19-9
Abstract #1076TiP
Poster Presentation
Developmental Therapeutics
Oct 23, 2026: 3:15 – 4:00 pm CEST
Health Economics and Outcomes Research (HEOR)
Real-world progression-free survival (rwPFS) from chemotherapy initiation in patients with HR+/HER2– metastatic breast cancer (mBC) in the US
Abstract #1880P
Poster Presentation
HR+ Breast Cancer
Oct 24, 2026: 12:00 – 12:45pm CEST
Real-world outcomes with first-line pembrolizumab-based chemoimmunotherapy in patients with advanced/metastatic non-small cell lung cancer in the USA
Abstract #2705P
Poster Presentation
NSCLC, Metastatic
Oct 26, 2026: 12:00 – 12:45pm CET

(Press release, BioNTech, OCT 19, 2026, View Source [SID1234673554])

On October 19, 2026 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported the publication of FURTHER Phase 1b (FURMO-002; NCT05364073) results of firmonertinib in Cancer Cell, highlighting the preclinical and clinical findings supporting its potential, if approved, as the first oral, chemotherapy-free targeted therapy for treatment-naïve patients with advanced EGFR PACC-mutant non-small cell lung cancer (NSCLC).

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EGFR PACC-mutant NSCLC is one of the largest underserved patient populations within EGFR-driven lung cancer. Accounting for approximately 12% of EGFR-mutant tumors, these patients currently have no established targeted standard of care, and are typically treated with therapies that were not designed for their unique biology, resulting in limited clinical benefit. This longstanding treatment gap underscores the significant opportunity for a targeted therapy purpose-built for EGFR PACC mutations.

"The publication demonstrated that firmonertinib’s unique molecular structure fits the EGFR PACC mutations very well, so this TKI has a unique potential high anti-tumor activity for this lung cancer patient population" said Xiuning Le, MD, Ph.D., associate professor of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Anderson Cancer Center, Houston, Texas. "Now the preclinical findings translated to prospective clinical trial data, resulting in robust confirmed response and progression-free survival. We believe this is very encouraging to EGFR PACC-mutant NSCLC patients".

"We believe firmonertinib has the potential to change the treatment paradigm for EGFR PACC-mutant NSCLC, and these findings give us a strong foundation for our global Phase 3 ALPACCA trial," said Bing Yao, Ph.D., CEO of ArriVent. "We continue to enroll patients in our global Phase 3 ALPACCA trial as we seek to address this area of high unmet medical need where there is no current standard of care."

Key Highlights for Firmonertinib from the Publication Include:

· Enhanced in vitro potency vs. osimertinib: Firmonertinib’s unique trifluoroethoxy side chain creates additional contact points for binding to PACC-mutated EGFR’s kinase domain.
· Robust, durable clinical activity: 43% (160 mg) and 68% (240 mg) confirmed overall response rate (ORR), with 11.1- and 16.0-months median progression free survival (PFS), both by blinded independent central review (BICR), respectively in front-line EGFR PACC-mutant NSCLC.
· Meaningful intracranial activity: 47% (8/17) confirmed intracranial ORR, including 41% complete responses among 17 patients with baseline brain metastases.
· ctDNA clearance correlated with outcomes: 80% of evaluable patients achieved complete molecular response by cycle 3, with higher ORR (70% vs. 20%) and longer median PFS (15.1 vs. 3.0 months) than those without clearance.
· Manageable, consistent safety profile: Treatment-related adverse event rates were consistent with firmonertinib’s safety profile in prior clinical studies.

Based on these and other findings, ArriVent is evaluating firmonertinib versus investigator’s choice of osimertinib or afatinib as first-line treatment for patients with locally advanced or metastatic EGFR PACC-mutant NSCLC (FURMO-006; NCT07185997).

About Firmonertinib

Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. Firmonertinib is approved in China for first-line advanced non-small-cell lung cancer (NSCLC) patients with EGFR exon 19 deletion or L858R mutations, with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, both known as EGFR classical mutations, as well as for with exon 20 insertion mutations who have experienced disease progression during or after platinum-containing chemotherapy, or who are intolerant to platinum-containing chemotherapy.

Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations.

Firmonertinib is currently being studied and in a global Phase 3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA; NCT07185997).

About EGFR mutant NSCLC

Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need.

About EGFR PACC mutations

P-loop and αC-helix compressing (PACC) EGFR mutations are a distinct set of approximately 70 mostly missense activating mutations within the kinase domain of EGFR. They are similar to Exon 20 insertion mutations in narrowing the drug binding pocket to affect tyrosine kinase inhibitor activity. PACC mutations are diagnosed through commercially available NGS and most PCR tests. Patients with PACC mutations have limited treatment options, and there is no broadly utilized standard of care treatment for first-line PACC mutant patients.

(Press release, ArriVent Biopharma, OCT 19, 2026, View Source [SID1234673553])

On October 19, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplement expanding its U.S. REGAIN (Recurrent Glioblastoma Alpha DaRT Intratumoral Therapy) trial. The Company also announced that an abstract has been accepted for presentation at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO), to be held November 12 – 15, 2026, in Philadelphia.

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Under the approved supplement, REGAIN can now enroll up to 20 patients, up from the previously approved 10 patients, at the three U.S. academic cancer centers authorized to participate. Based on initial discussions, the Company believes that the expanded trial could generate additional data on the use of Alpha DaRT to treat recurrent glioblastoma, which may support market submission requirements for Alpha DaRT in patients with this disease.

The updated protocol also opens the study to patients with IDH-mutant grade 4 tumors, which the World Health Organization has classified separately from glioblastoma since 2021, adds progression-free survival as a secondary endpoint; and introduces regular quality-of-life assessments. The protocol also provides for an additional interim analysis six months after the fifth patient’s treatment, which occurred in July 2026.

The SNO abstract was submitted by REGAIN principal investigator Dr. Joshua Palmer, Radiation Oncologist at the OSUCCC – James. Titled "First-In-Human Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma: Safety Interim Analysis (REGAIN)," it will be presented on Friday, November 13, from 7:30 to 9:30 p.m. ET, and will include new trial data, building on the interim results which Alpha Tau had previously announced on May 11, 2026 from the first three treated patients. According to SNO, its annual meeting is the world’s largest neuro-oncology conference, regularly attracting more than 3,000 researchers and clinician-scientists from over 40 countries.

Uzi Sofer, CEO of Alpha Tau, stated: "The FDA’s approval to expand REGAIN represents an important milestone in our efforts to advance Alpha DaRT as a potential treatment option for patients with recurrent glioblastoma, a devastating disease with extremely limited treatment options. We believe that the expanded clinical program, together with the additional interim analysis included in the approved protocol, may help inform our future regulatory development strategy in this indication. We are particularly pleased that updated clinical data from REGAIN will be presented at SNO, one of the world’s leading forums for neuro-oncology research."

Robert Den, MD, Chief Medical Officer of Alpha Tau, commented: "The expanded REGAIN protocol will allow us to collect a broader and more comprehensive clinical dataset, including measures of progression-free survival, overall survival, and quality of life. These assessments are particularly important in recurrent glioblastoma, where extending survival while preserving neurological function and quality of life remains a major clinical challenge. We look forward to presenting updated clinical findings at SNO and continuing to build the evidence needed to guide the future development of Alpha DaRT in this indication. We are grateful to Dr. Joshua Palmer and his team at The Ohio State University for their leadership and dedication to this important study, and we look forward to sharing its progress with the medical and scientific community."

About the REGAIN Study

The REGAIN study is a prospective, interventional, open-label, single-arm, multicenter study designed to evaluate the feasibility and safety of Alpha DaRT for the potential treatment of recurrent glioblastoma. The study is expected to enroll up to 20 U.S. patients whose recurrent glioblastoma or IDH-mutant grade 4 tumor is not amenable to surgical resection and who have undergone a prior course of central nervous system radiation. Secondary objectives include radiographic local tumor control, the rate of pseudo-progression, overall survival and progression-free survival, and patients’ quality of life. Additional information about the trial can be found at View Source

(Press release, Alpha Tau Medical, OCT 19, 2026, View Source [SID1234673552])

On October 19, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in differentiated targeted radiotherapies with the potential to transform cancer treatment, reported investors and the scientific community that clinical and preclinical data for ATNM-400 will be presented today at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM), being held October 17–21, 2026, in Vienna, Austria.

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The clinical oral presentation will feature early data from the ongoing first-in-human Phase 1 dose-escalation study of ATNM-400 in metastatic castration-resistant prostate cancer (mCRPC). It will describe evaluation of the Zirconium-89-labeled imaging counterpart, including safety, biodistribution, dosimetry and serial PET assessment of tumor uptake and clearance, to inform development and dosing of Actinium-225-labeled ATNM-400.

The preclinical oral presentation will feature studies of ATNM-400 in KRAS- and ALK-driven non-small cell lung cancer (NSCLC) models, including evaluation as monotherapy and in combination with KRAS or ALK inhibitors. The presentation builds on earlier EGFR-mutant research and will discuss the rationale for mutation-agnostic development across lung cancer subtypes.

ATNM-400 is an investigational, first-in-class Actinium-225 antibody radioconjugate targeting HER3. The program is being developed to expand targeted radiotherapy beyond PSMA in prostate cancer and explore its potential across multiple solid tumors, as a monotherapy and in combination with established treatments.

EANM 2026 Presentation Details

Both sessions: Monday, October 19, 2026, 4:45–6:15 p.m. CEST (10:45 a.m.–12:15 p.m. EDT).

Clinical prostate cancer presentation | OP-525
First-in-human Phase 1 study of ATNM-400 in mCRPC
Session 1111: Theranostics Track: Prostate Cancer Therapy II | Hall G1

Preclinical lung cancer presentation | EPS-149
ATNM-400 in KRAS- and ALK-driven NSCLC models
Session 1109: Translational Imaging and Therapy | Hall G2

(Press release, Actinium Pharmaceuticals, OCT 19, 2026, View Source [SID1234673551])

On October 19, 2026 Imugene Limited (ASX: IMU), a clinical-stage cellular therapy company, reported two further responses in its ongoing Phase 1b basket study of azer-cel (azercabtagene zapreleucel), including one CR in the CAR Tnaïve Cohort 2 and one PR in the Bruton Tyrosine Kinase inhibitor (BTKi) combination Cohort 3.

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In Cohort 2, a patient with marginal zone lymphoma (MZL) achieved CR at their day 28 assessment. Cohort 2 has demonstrated an Overall Response Rate (ORR) of 81%, with 22 of 27 patients achieving a response.

In Cohort 3, a patient with Richter’s Transformation who had previously demonstrated SD has now converted to a PR. Cohort 3 evaluates azer-cel in combination with a BTKi in patients whose disease has progressed on prior BTKi therapy.

Cohort 3 has now demonstrated an ORR of 86%, with six of seven patients achieving a response. All patients enrolled in this combination cohort have previously received and progressed on BTKi therapy, representing a heavily pre-treated population with high unmet medical need and fewer remaining treatment options.

These latest results add to the growing body of clinical evidence supporting azer-cel across diverse B-cell malignancies and patient populations with significant unmet medical need.Further clinical updates will be reported as patient enrolment continues and data matures.

About the Phase 1b azer-cel trial

The ongoing, open-label Phase 1b trial of azer-cel in the U.S. and Australia evaluates three main patient populations: CAR T-relapsed patients, CAR T-naïve patients, and BTKi combination cohort of patients with B-cell malignancies who previously progressed on BTKi therapy. Across a broad range of non-Hodgkin lymphomas (including FL, CLL/SLL, MZL, WM, and MCL), treatment with azer-cel, lymphodepletion, and IL-2 has yielded meaningful clinical activity including multiple complete responses in the BTKi cohort, with a manageable safety and tolerability profile.

(Press release, Imugene, OCT 19, 2026, View Source [SID1234673549])