Trastuzumab pamirtecan, an investigational HER2-targeted antibody-drug conjugate, met the first efficacy endpoint in a Section 2 cohort of closely pre-treated sufferers with HER2-expressing, recurrent endometrial most cancers, an space of excessive unmet medical needData demonstrated clinically significant antitumor exercise throughout all HER2 expression ranges and a manageable security profile, with centrallyi HER2-tested sufferers displaying a confirmed goal response price of 47.9% in all evaluable sufferers, 49.3% in sufferers with prior immune checkpoint inhibitor therapy, and a median progression-free survival of 8.1 monthsLargest trial up to now to report outcomes for a HER2-targeted antibody-drug conjugate on this indication helps potential of trastuzumab pamirtecan in real-world affected person populations, together with sufferers with decrease HER2 expression ranges and prior checkpoint inhibitor therapy
MAINZ, Germany, April 11, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) at this time introduced constructive outcomes from the first evaluation of a Section 2 cohort evaluating trastuzumab pamirtecan (BNT323/DB-1303) in sufferers with HER2-expressing, superior endometrial most cancers whose illness progressed on or after first-line chemotherapy with or with out prior checkpoint inhibitor therapy. This cohort is a part of a worldwide Section 1/2a medical trial (NCT05150691) investigating the HER2-targeted antibody-drug conjugate (“ADC”) candidate trastuzumab pamirtecan in a number of strong tumors.
The information demonstrated clinically significant efficacy and a manageable security profile for trastuzumab pamirtecan monotherapy throughout all HER2 immunohistochemistry (“IHC”) expression ranges (IHC1+, IHC2+, IHC3+)ii. Outcomes had been constant amongst sufferers no matter prior checkpoint inhibitor therapy. The information will likely be introduced at this time in an oral session on the 2026 Society of Gynecologic Oncology (“SGO”) Annual Assembly on Ladies’s Cancers in San Juan, Puerto Rico.
“Endometrial cancer is one of the few cancers with an increasing mortality rate,1 and there is an urgent need for new treatment options, especially for patients with recurrent disease with lower HER2 expression levels where current standard-of-care chemotherapy offers only a 15 % response rate2,” mentioned Bhavana Pothuri, M.D., Medical Director of the Scientific Trials Workplace (CTO) and Director of Gynecologic Oncology Analysis on the NYU Langone Perlmutter Most cancers Middle. “We are encouraged by these results for trastuzumab pamirtecan, which showed clinically meaningful responses across all HER2 levels. Importantly, these results were seen in a broad patient population that reflects real-world clinical practice, including patients who have received prior immune checkpoint inhibitor treatment and those with visceral metastases.”
The evaluation of the Section 2 cohort included 145 sufferers with superior or metastatic HER2-expressing endometrial most cancers whose illness had progressed following first- or later strains of remedy. This cohort met its main efficacy endpoint of goal response price (“ORR”) evaluated in 73 sufferers beforehand handled with checkpoint inhibitor remedy and confirmed HER2 standing by central testing, displaying a confirmed ORR of 49.3% (95% CI: 37.4, 61.3). In all centrally examined sufferers (n=96) the confirmed ORR was 47.9% (95% CI: 37.6, 58.4) with a median progression-free survival (“mPFS”) of 8.1 months (95% CI: 5.5, 11.8).
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Among the many 143 efficacy-evaluable sufferers by locali HER2 standing testing, the confirmed ORR was 44.1% (95% CI: 35.8, 52.6). Trastuzumab pamirtecan constantly demonstrated encouraging antitumor exercise throughout all HER2 expression ranges, with comparable outcomes whether or not HER2 testing was carried out regionally or centrally. Amongst sufferers with native HER2 testing, the confirmed ORR was 33.9% (IHC1+) and 40.4% (IHC2+) in sufferers with decrease ranges of HER2 expression, and 73.1% (IHC3+) in sufferers with larger HER2 expression ranges. The median period of response (“mDoR”) was 10.3 months. mPFS for all evaluable sufferers (n=145), whether or not they had obtained prior checkpoint inhibitor therapy or not, was 8.0 months (95% CI: 5.6, 8.3).
The protection profile was manageable and as anticipated for HER2-targeted ADCs. The most typical treatment-related antagonistic occasions (TRAEs) had been low-grade nausea, anemia, platelet rely lower, and low-grade fatigue. Grade ≥3 treatment-related antagonistic occasions (TRAEs) had been reported in 68 of 145 (46.9%) sufferers. Adjudicated instances of interstitial lung illness (“ILD”) or pneumonitis of grade ≥3 occurred in 4.8% of sufferers and had been per the recognized security profile of HER2-targeted ADC therapies. The vast majority of occasions grade 3 or larger had been effectively manageable with acceptable medical interventions.
“These positive results in patients with endometrial cancer including those with lower HER2 expression levels support the potential of trastuzumab pamirtecan,” mentioned Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “HER2 remains an important therapeutic target, particularly in gynecologic cancers and breast cancer. We are continuing to advance trastuzumab pamirtecan, both as a monotherapy and in novel-novel treatment combination approaches, with the aim to address the significant unmet medical needs in the treatment of patients with HER2-driven tumors.”
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Trastuzumab pamirtecan obtained Quick Observe and Breakthrough Remedy designations from the U.S. Meals and Drug Administration (“FDA”) for the therapy of endometrial most cancers in 2023. A world confirmatory Section 3 medical trial Fern-EC-01 (NCT06340568) evaluating trastuzumab pamirtecan monotherapy in comparison with chemotherapy in beforehand handled sufferers with HER2-expressing, recurrent endometrial most cancers is ongoing. BioNTech and DualityBio plan to file a biologics license software (“BLA”) in 2026, topic to regulatory suggestions from the FDA.
About trastuzumab pamirtecanTrastuzumab pamirtecan (BNT323/DB-1303) is a third-generation topoisomerase-1 inhibitor-based ADC concentrating on HER2 and is being developed by BioNTech and Duality Biologics. Trastuzumab pamirtecan was constructed from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (“DITAC”) platform. HER2 is a surface-expressed protein on strong tumors and has been linked to the aggressive progress and unfold of most cancers cells. Preclinical information and preliminary medical information for trastuzumab pamirtecan point out its potential to focus on HER2 receptors on strong tumors regardless of expression stage with a manageable security profile and a doubtlessly expanded therapeutic window.
Trastuzumab pamirtecan is being evaluated in an ongoing Section 1/2 trial (NCT05150691) in sufferers with superior/metastatic strong tumors, and in two international Section 3 medical trials. Fern-EC-01, a randomized Section 3 medical trial (NCT06340568) evaluating trastuzumab pamirtecan in contrast with investigator’s alternative of single agent chemotherapy in beforehand handled sufferers with HER2-expressing superior recurrent endometrial most cancers, is at present enrolling sufferers. DYNASTY-Breast02, a Section 3 medical trial (NCT06018337) evaluating trastuzumab pamirtecan in sufferers with Hormone Receptor-positive (“HR+”) and Human Epidermal Progress Issue Receptor 2 (“HER2”)-low, metastatic breast most cancers which have progressed on hormone and/or cyclin-dependent kinase 4/6 (“CDK4/6”) remedy, is absolutely enrolled and anticipated to learn out this 12 months.
Concerning the Section 1/2a trialThe international, multi-cohort Section 1/2a medical trial (NCT05150691) evaluated the security and tolerability of trastuzumab pamirtecan in sufferers with superior strong tumors that specific HER2. Cohort 2b is a Section 2 enlargement cohort which enrolled 145 sufferers with superior/metastatic HER2-expressing endometrial most cancers whose illness had progressed after first- and later strains of remedy. The HER2 standing was decided for all sufferers by way of native testing and, the place attainable, confirmed by way of central testing. The first endpoints had been goal response price in sufferers with prior checkpoint inhibitor therapy with HER2 expression, confirmed by retrospective central testing, and security. Secondary endpoints included ORR, DoR, DCR, PFS and OS.
About BioNTechBiopharmaceutical New Applied sciences (BioNTech) is a worldwide subsequent technology immunotherapy firm pioneering novel investigative therapies for most cancers and different critical ailments. BioNTech exploits a wide selection of computational discovery and therapeutic modalities with the intent of speedy improvement of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to handle the complete continuum of most cancers contains mRNA most cancers immunotherapies, next-generation immunomodulators and focused therapies comparable to antibody-drug conjugates (ADCs) and revolutionary chimeric antigen receptor (CAR) T cell therapies. Primarily based on its deep experience in mRNA improvement and in-house manufacturing capabilities, BioNTech and its collaborators are researching and creating a number of mRNA vaccine candidates for a spread of infectious ailments alongside its various oncology pipeline. BioNTech has established a broad set of relationships with a number of international and specialised pharmaceutical collaborators, together with Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, Pfizer and Regeneron.
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i Central testing refers to HER2 expression stage evaluation carried out at a single, designated laboratory, whereas native testing refers to evaluation carried out at a affected person’s particular person trial website or native laboratory.ii HER2 immunohistochemistry (“IHC”) expression ranges: IHC1+ = low expression, IHC2+ = average expression, IHC3+ = excessive expression
1 Nationwide Most cancers Institute. Most cancers Stat Info: Uterine Most cancers. https://seer.most cancers.gov/statfacts/html/corp.html. Accessed March 17, 2026. 2Makker V, et al. J Clin Oncol. 2023 Apr 14;41(16):2904–2910.
