Immunomedics’ early Phase I/II safety balances good efficacy in TNBC for further development, clinical use optimism – experts

11 Oct 2016

Immunomedics’ (NASDAQ:IMMU) Phase I/II Sacituzumab govitecan (IMMU-132) carries further development and market promise in triple-negative breast cancer (TNBC) due to a targeted approach with fewer side effects, said experts.

The 2015 early Phase I/II study (NCT01631552) results have been clinically significant due to responses in heavily treated patients where standard chemotherapies only improve progression-free survival by a few months, said experts. However, all eyes are on interim results due at year end, which would indicate the durability of these responses to solidify any confidence in sacituzumab as a worthy clinic candidate for TNBC. Immunomedics plans to either publish the updated Phase II data in a medical journal or present these data at the San Antonio Breast Cancer Symposium (SABCS), Texas, 6-10 December, whichever comes first, said Cheng Chau, senior director, Investor Relations and Company secretary, Immunomedics.

While a mid-2017 biologics license application (BLA) filing for accelerated approval, based on six month follow up data, is planned, experts were reluctant to comment on whether data from 100 patients – what the FDA requires – would be enough to secure an approval. However, they emphasized the need for longer term data to assert the efficacy and safety of the drug.

The FDA submission will be based on data from the TNBC patients in the Phase I/II basket study (NCT01631552), said Chau. Peak sales for sacituzumab are estimated to be USD 207m in 2025, according to one analyst report.

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