BioNTech lung cancer drug lifts survival to 18.5 mo
BioNTech’s CTLA-4 antibody gotistobart improved survival versus docetaxel in non-pivotal Phase 3 squamous NSCLC data, with pivotal stage ongoing.
Rhea-AI Filing Summary
BioNTech SE (BNTX) reported updated stage 1 data from the global Phase 3 PRESERVE-003 trial of gotistobart (BNT316/ONC-392) in patients with metastatic squamous non-small cell lung cancer whose disease progressed after prior immunotherapy and chemotherapy. In this randomized comparison versus docetaxel, gotistobart monotherapy showed a statistically significant, clinically meaningful improvement in median overall survival.
Among 87 randomized patients (45 gotistobart; 42 docetaxel) and a median follow-up of 25.4 months as of July 17, 2026, median overall survival was 18.5 months with gotistobart versus 10.0 months with docetaxel (hazard ratio 0.56, nominal p=0.0295). Grade ≥3 treatment-related adverse events occurred in 44.4% of patients on gotistobart and 48.8% on docetaxel, indicating a manageable safety profile. The pivotal stage 2 portion of PRESERVE-003 is ongoing at more than 160 sites globally, and gotistobart holds U.S. Fast Track and Orphan Drug Designations and a Breakthrough Therapy Designation in China for related NSCLC indications.
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Key Figures
Median overall survival with gotistobart: 18.5 months
Median overall survival with docetaxel: 10.0 months
Hazard ratio for overall survival: 0.56
+5 more
8 metrics
Median overall survival with gotistobart
18.5 months
Stage 1 of PRESERVE-003 in metastatic squamous NSCLC
Median overall survival with docetaxel
10.0 months
Control arm in PRESERVE-003 stage 1
Hazard ratio for overall survival
0.56
Gotistobart versus docetaxel in PRESERVE-003 stage 1
Nominal p-value
0.0295
Overall survival comparison gotistobart vs docetaxel
Patients randomized
87 patients
45 gotistobart; 42 docetaxel in PRESERVE-003 stage 1
Median follow-up
25.4 months
As of July 17, 2026 data cut-off
Grade ≥3 TRAEs with gotistobart
44.4%
20 of 45 patients in the gotistobart arm
Grade ≥3 TRAEs with docetaxel
48.8%
20 of 42 patients in the docetaxel arm
Key Terms
median overall survival, hazard ratio, CTLA-4-targeting immunotherapy, regulatory T cells, +2 more
6 terms
median overall survival medical
"Gotistobart demonstrated a median overall survival of 18.5 months"
Median overall survival is the middle point of how long patients live after starting treatment, meaning half live longer and half live shorter. It helps doctors understand how effective a treatment is and gives patients an idea of what to expect about their future.
hazard ratio medical
"docetaxel (HR: 0.56; nominal p-value=0.0295)"
A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.
CTLA-4-targeting immunotherapy medical
"Gotistobart is an investigational CTLA-4-targeting immunotherapy"
regulatory T cells medical
"designed to selectively deplete regulatory T cells"
Regulatory T cells are a specialized type of immune cell that act like a brake on the body’s defense system, preventing it from attacking healthy tissue or causing chronic inflammation. They matter to investors because drugs that increase or block these cells can change treatment success and safety in areas such as autoimmune disease, organ transplants, and cancer immunotherapy, affecting clinical trial results, approval chances, and commercial value.
Fast Track Designation regulatory
"Gotistobart received Fast Track Designation from the U.S. Food and Drug Administration"
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
Breakthrough Therapy Designation regulatory
"received Breakthrough Therapy Designation from China’s National Medical Products Administration"
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did BioNTech (BNTX) report from the PRESERVE-003 Phase 3 trial?
BioNTech reported first median overall survival data from stage 1 of PRESERVE-003, showing 18.5 months median overall survival with gotistobart versus 10.0 months with docetaxel in previously treated metastatic squamous NSCLC, with a hazard ratio of 0.56 and nominal p=0.0295.
How many patients were included in the gotistobart analysis for BNTX?
The analysis included 87 patients with metastatic squamous NSCLC, randomized to gotistobart (45 patients) or docetaxel (42 patients), with a median follow-up of 25.4 months at the July 17, 2026 data cut-off.
What was the safety profile of gotistobart in BioNTech’s PRESERVE-003 stage 1 data?
The safety profile of gotistobart was described as consistent with prior data and manageable. Grade ≥3 treatment-related adverse events occurred in 44.4% of gotistobart patients (20/45) and 48.8% of docetaxel patients (20/42).
What regulatory designations has gotistobart received according to BioNTech (BNTX)?
Gotistobart received U.S. FDA Fast Track Designation in 2022 for metastatic NSCLC after anti‑PD‑(L)1 therapy, Orphan Drug Designation for squamous NSCLC in 2025, and Breakthrough Therapy Designation from China’s NMPA in 2025.
What is the current status of the PRESERVE-003 pivotal stage for BioNTech’s gotistobart?
The pivotal stage 2 portion of PRESERVE‑003, evaluating gotistobart versus docetaxel in squamous NSCLC patients who progressed on PD‑(L)1 inhibitors and platinum chemotherapy, is currently ongoing at more than 160 sites globally.
How does gotistobart work according to BioNTech’s 6-K disclosure?
Gotistobart is described as an investigational CTLA-4-targeting immunotherapy designed to selectively deplete regulatory T cells in the tumor microenvironment, using a pH-sensitive monoclonal antibody mechanism that enables CTLA-4 recycling and aims to restore anti-tumor immune activity.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
FOR THE MONTH OF SEPTEMBER 2026
COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K
On September 14, 2026, BioNTech SE and OncoC4, Inc. announced the first median overall survival (“OS”) data from the non-pivotal stage 1 of the global randomized PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart (also known as BNT316 or ONC-392), in patients with squamous non-small lung cancer (“NSCLC”) whose disease progressed on prior immunotherapy and chemotherapy. The press release is attached as Exhibit 99.1.
SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BioNTech SE | ||||||||||||||
By: | /s/ Ramon Zapata-Gomez | By: | /s/ Dr. Sierk Poetting | |||||||||||
Name: Ramon Zapata-Gomez | Name: Dr. Sierk Poetting | |||||||||||||
Title: Chief Financial Officer | Title: Chief Operating Officer | |||||||||||||
Date: September 14, 2026
EXHIBIT INDEX
Exhibit | Description of Exhibit | ||||
99.1 | BioNTech and OncoC4 Present Updated Data Showing Gotistobart Nearly Doubled Median Overall Survival versus Standard-of-Care Chemotherapy in Previously Treated Squamous Non-Small Cell Lung Cancer Patients | ||||
Exhibit 99.1
BioNTech and OncoC4 Present Updated Data Showing Gotistobart Nearly Doubled Median Overall Survival versus Standard-of-Care Chemotherapy in Previously Treated Squamous Non-Small Cell Lung Cancer Patients
•Gotistobart continues to show potential as chemotherapy-free monotherapy to reignite anti-tumor immunity in previously treated patients with squamous non-small cell lung cancer, where median survival with current standard of care treatments is less than one year1
•Gotistobart demonstrated a median overall survival of 18.5 months compared to 10.0 months with standard-of-care chemotherapy in updated data from stage 1 of the PRESERVE-003 Phase 3 clinical trial, nearly doubling median survival in this patient population
•Findings are consistent with gotistobart’s differentiated mechanism of action as an investigational immunomodulator that selectively enhances regulatory T cell depletion through CTLA-4-targeting in the tumor microenvironment
MAINZ, Germany, and ROCKVILLE, USA, September 14, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”) today announced the first median overall survival (“OS”) data from the non-pivotal stage 1 of the global randomized PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart (also known as BNT316 or ONC-392), in patients with squamous non-small lung cancer (“NSCLC”) whose disease progressed on prior immunotherapy and chemotherapy. Gotistobart is an investigational CTLA-4-targeting immunotherapy designed to selectively deplete regulatory T cells (“Tregs”) within the tumor microenvironment and restore anti-tumor immune activity.
The data showed that treatment with gotistobart led to a statistically significant and clinically meaningful OS benefit, nearly doubling survival compared with standard-of-care chemotherapy in this patient population. The data were presented at the International Association for the Study of Lung Cancer (“IASLC”) 2026 World Conference on Lung Cancer (“WCLC”).
“Patients with squamous NSCLC continue to face limited treatment options after progression on immunotherapy. Current survival expectations with established therapies remain less than a year, and despite numerous development efforts, chemotherapy has remained the standard of care in this setting for more than a decade,” said Rama Balaraman, M.D., Principal Investigator and medical oncologist at Ocala Oncology Center, Florida, United States. “The magnitude of the survival benefit observed with gotistobart as a chemotherapy-free treatment approach in the PRESERVE-003 clinical trial is highly encouraging. If confirmed in the pivotal portion of the Phase 3 trial, these findings could transform the standard of care in a setting where new therapies are urgently needed.”
At the data cut-off on July 17, 2026, with a median follow-up of 25.4 months, 87 patients with metastatic squamous NSCLC had been randomized to receive either gotistobart monotherapy 6 mg/kg with two 10 mg/kg loading doses (N=45) or docetaxel 75 mg/m2 (N=42) in the second-line or later treatment setting. The median OS was 18.5 months for patients treated with gotistobart compared to 10.0 months for patients treated with docetaxel (HR: 0.56; nominal p-value=0.0295). The safety profile of gotistobart was consistent with previously reported data and remained manageable. Grade ≥3 treatment-related adverse events (“AEs”) were reported in 20/45 (44.4%) patients receiving gotistobart and 20/42 (48.8%) patients receiving docetaxel.
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel therapeutic options depends on the ability to re-engage a suppressed or exhausted anti-tumor immune response and overcome acquired resistance. This update highlights gotistobart’s unique mode of action and our ambition to translate our deep understanding of the immune system into meaningful survival benefit for patients with lung cancer – particularly in areas where patients still need more. We look forward to continuing our work with our colleagues at OncoC4 to further explore and realize gotistobart’s full potential.”
“The data support the differentiated mechanism of action of gotistobart as a tumor microenvironment-selective Treg modulator and reinforce our confidence in the therapeutic potential of this distinct CTLA-4-targeting approach to meaningfully shift the treatment landscape in this indication,” said Pan Zheng, M.D., Ph.D., Co-Founder and Chief Medical Officer at OncoC4. “We are encouraged by the clinical activity and safety profile observed to date and remain focused on advancing gotistobart for patients with this difficult-to-treat disease.”
The pivotal stage 2 portion of PRESERVE-003 is currently ongoing at more than 160 sites globally. Gotistobart previously demonstrated a clinically meaningful OS benefit and durable anti-tumor activity versus docetaxel in stage 1 of the PRESERVE-003 Phase 3 trial in patients with squamous NSCLC who had progressed on PD-(L)1 inhibitors. This data was published in Nature Medicine and presented at the 2026 European Lung Cancer Congress (“ELCC”) and the IASLC ASCO 2025 North America Conference on Lung Cancer (“NACLC”).
About the PRESERVE-003 clinical trial
PRESERVE-003 (NCT05671510; EUCT:2023-505311-20-01; CTR20232927) is a two-stage, open-label Phase 3 trial evaluating the efficacy and safety of gotistobart as monotherapy compared to the standard-of-care chemotherapy (docetaxel) in squamous NSCLC patients, who have progressed on PD-(L)1 inhibitors and platinum-based chemotherapy. The non-pivotal stage of the trial included all NSCLC patients. The ongoing pivotal stage enrolled patients with squamous NSCLC. The primary endpoint is overall survival. Secondary endpoints include overall response rate, progression-free survival, and safety profile.
About gotistobart (BNT316/ONC-392)
Gotistobart (BNT316/ONC-392) is an investigational immunotherapy that enhances Treg depletion within the tumor microenvironment through targeting CTLA-4 to reignite antitumor immunity and which is being jointly developed by BioNTech and OncoC4.2,3,4,5,6,7,8,9 As a pH-sensitive monoclonal antibody, gotistobart is designed to enable CTLA-4 protein recycling. After binding to the CTLA-4 receptor on the cell surface, the complex is internalized, and the pH change causes the antibody to unbind, allowing CTLA-4 to return to the surface to preserve the immune checkpoint function at peripheral organs and to enhance anti-tumor immunity in the tumor microenvironment.9
Gotistobart is currently in late-stage clinical development as a monotherapy and as a component of combination therapy in various cancer indications. Gotistobart received Fast Track Designation from the U.S. Food and Drug Administration (“FDA”) in 2022 for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy and Orphan Drug Designation for the treatment of patients with squamous NSCLC in 2025. The candidate also received Breakthrough Therapy Designation from China’s National Medical Products Administration (“NMPA”) in 2025.
About squamous non-small cell lung cancer
With a 5-year relative survival rate of 15% and a median overall survival of 11 months in the United States (2000-2017), squamous NSCLC is a devastating disease with limited treatment options.1 Current standard-of-care includes surgery and radiotherapy in combination with chemotherapy.9 Treatment options for second-line therapy after first-line immunotherapy and chemotherapy are limited to chemotherapy or palliative therapy in advanced/metastatic squamous NSCLC and remain more limited than for non-squamous NSCLC.
About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive
progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
For more information, please visit www.BioNTech.com.
BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the collaboration with OncoC4; BioNTech and OncoC4’s ability to successfully co-develop and co-commercialize gotistobart (also known as BNT316 or ONC-392), if approved; the rate and degree of market acceptance of gotistobart, if approved; the initiation, timing, progress, and results of BioNTech’s research and development programs, including data from the non-pivotal stage 1 of the global randomized Phase 3 trial PRESERVE-003 and statements regarding the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations, including expectations regarding the potential indications in which gotistobart may be approved, if at all; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; and discussions with regulatory agencies. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; and other factors not known to BioNTech at this time.
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
About OncoC4
Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the treatment of cancer and immunological diseases. OncoC4’s pipeline features assets with first-in-class
and best-in-class potential targeting both novel and well-validated targets across oncology and immunological diseases. Among them, AI-081 is a wholly owned bispecific antibody candidate targeting PD-1 and VEGF that is currently in phase 2 trial for oncology indications. ONC-841 is a first-in-class anti-SIGLEC-10 antibody currently in a Phase 2 trial for oncology indications and a Phase 1 trial for neurodegenerative diseases. OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer.
More information: www.oncoc4.com.
CONTACTS
BioNTech:
Investor Relations
Douglas Maffei, Ph.D.
Investors@BioNTech.de
Media Relations
Jasmina Alatovic
Media@BioNTech.de
OncoC4:
Investor Relations
Ryan Cui
ir@oncoc4.com
Media Relations
Helen Schiltz
hschiltz@oncoc4.com
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2 Du X, et al. Cell Res. 2018;28:433–47
3 Du X, Cell Res. 2018;28:416–32
4 Gao H, et al. Cell Discov. 2020;6:79
5 Hale G, et al. MAbs. 2024;16:2406539
6 Liu R, et al. bodies (Basel). 2020;9:64
7 Simpson TR, et al. J Exp Med. 2013;210:1695–710;
8 Mellman I, et al. Immunity. 2023;56:2188–205.
9 American Cancer Society (2025) Treatment Choices for Non-small Cell Lung Cancer, by Stage, online at: https://www.cancer.org/cancer/types/lung-cancer/treating-non-small-cell/by-stage.html