On Monday, BioNTech SE (NASDAQ:BNTX) and DualityBiologics (Suzhou) Co., Ltd. announced that their Phase 3 DYNASTY-Breast02 trial met its primary endpoint.
But the drugmakers noted that the treatment offers limited potential benefit in the metastatic breast cancer landscape.
Modest Survival Gains In Phase 3 Trial
The study evaluated trastuzumab pamirtecan against physician-selected chemotherapy in chemotherapy-naïve patients with HR+/HER2-low metastatic breast cancer following endocrine therapy.
The treatment achieved a statistically significant, yet modest improvement in progression-free survival.
Meanwhile, overall survival data remained immature during this interim analysis.
Safety Findings Show Increased Lung Risks
Investigators documented a higher rate of interstitial lung disease compared to earlier studies of trastuzumab pamirtecan.
While most incidents presented as Grade 1 and 2 cases, a small percentage of patients suffered severe and fatal Grade 3 to 5 events.
The therapy otherwise maintained an overall safety profile consistent with earlier trials, with no new safety signals emerging.
Companies Weigh Strategic Next Steps
BioNTech and DualityBio will evaluate the clinical data to determine their upcoming plans.
Beyond this study, the two drug developers are testing trastuzumab pamirtecan across two additional programs: a Phase 3 study in HER2-expressing recurrent endometrial cancer and a Phase 1/2 trial in advanced solid tumors.
In October, BioNTech SE reported initial findings from the AHEAD-MERIT Phase 2/3 trial assessing BNT113, an investigational mRNA cancer immunotherapy.
The study evaluates BNT113 paired with Merck & Co. Inc.’s (NYSE:MRK) Keytruda (pembrolizumab) versus pembrolizumab alone as an initial treatment for patients suffering from advanced head and neck cancer.
During the initial analysis, the combination of BioNTech’s BNT113 and pembrolizumab did not achieve a statistically significant improvement in progression-free survival when compared directly to the pembrolizumab monotherapy.
BNTX Price Action: BioNTech shares were trading 2.57% lower at $85.85 during premarket trading on Monday, according to Benzinga Pro data.
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