Hop­ing to chal­lenge block­buster breast can­cer fran­chis­es, a small Dutch biotech says its ADC passed a PhI­II test

For the last sev­er­al years, an un­der-the-radar chal­lenger to Big Phar­ma’s breast can­cer fran­chis­es has been work­ing on an an­ti­body drug con­ju­gate in­volv­ing Her­ceptin. On Tues­day, the Dutch biotech re­vealed the pro­gram had met its pri­ma­ry end­point in a Phase III study, and they say they’re ready to make a deal.

Byondis’ ADC, com­bin­ing Her­ceptin with the ex­per­i­men­tal drug duo­car­mazine, reached its goal of a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment of pro­gres­sion-free sur­vival over physi­cian’s choice, the biotech said ear­ly Tues­day. None of the da­ta were re­vealed in the topline re­sults, but Byondis not­ed it plans to sub­mit its pitch to the FDA by the end of the year.

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