BioNTech and DualityBio are seeking the Chinese approval of trastuzumab pamirtecan after it outperformed Roche’s Kadcyla (trastuzumab emtansine) in a Phase III breast cancer trial.
In an interim analysis of the pivotal study (NCT06265428) conducted in China, the antibody-drug conjugate (ADC) – otherwise known as BNT323 or DB-1303 – offered patients statistically significant improvements in progression-free survival (PFS) over Kadcyla.
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This impact was observed in patients with human epidermal growth factor receptor 2 (HER2)-negative and hormone receptor (HR)-positive breast cancer previously treated with trastuzumab and taxane-based chemotherapy.
Though the drug’s co-developers BioNTech and Duality have not released any specific data from the analysis, the results mark a positive step forward, as the pair now plan to discuss the steps toward trastuzumab pamirtecan’s approval with China’s National Medical Products Administration (NMPA).
Duality’s global medical officer Dr Hua Mu also noted that the company will work with BioNTech to commercialise the ADC in HER2-positive breast cancer in the US and EU in a 5 September statement. To facilitate this, Duality is running the global DYNASTY-Breast-02 (NCT06018337) trial, which is set for primary completion in May 2026.
Breaking into the crowded ADC market
The early-stage outcome of this trial is a step in the right direction for BioNTech, which spent $170m on the global commercial rights to trastuzumab pamirtecan outside of mainland China, as well as the Hong Kong and Macau special administrative regions, in April 2023.
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By GlobalDataHowever, if the drug were to be approved, the German pharma would have to enter the ring with rival ADCs Kadcyla and AstraZeneca & Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan), which both work through identical mechanisms.
Currently, Enhertu is the standard of care (SoC) treatment for second-line patients, as it was proven to be superior in efficacy to Kadcyla in the DESTINY-Breast003 trial (NCT03529110).
As BioNTech and Duality’s drug has yet to be proven against the current SoC, analysts are questioning its potential market impact if it were to be approved in the US and EU.
“Trastuzumab pamirtecan’s win over Kadcyla suggests the drug’s competitiveness, but not its displacement of taxane, trastuzumab and pertuzumab (TTP) in the first line setting, or its superiority to Enhertu in the second line,” stated Biswajit Podder, oncology and haematology analyst at GlobalData.
“The drug’s US prospects hinge on the drug’s superiority of Enhertu, which is yet to be proven. We will need to see head-to-head evidence or compelling post-Enhertu activity for it to gain approval,” Podder added. “If approved, I would expect trastuzumab pamirtecan to be positioned after Enhertu, or where Enhertu is unsuitable until strong comparative data becomes available.”
Meanwhile, GlobalData’s senior healthcare analyst Jack Cuthbertson said: “While trastuzumab pamirtecan will most likely play a secondary role to Enhertu in the US/EU/Japanese markets, it could gain a more significant market share in China moving forward.”
Podder echoed this statement, noting that “if the HR+, HER2- trial readout is positive, with an acceptable interstitial lung disease profile, expect share gains versus single-agent chemotherapy in that large population, as well as incremental pressure on Enhertu’s market share”.
According to GlobalData’s Intelligence Center, Enhertu brought in $4.1bn worth of sales in 2024, with the drug forecasted to make $14.6bn for Daichii and AstraZeneca by 2031.
