Halozyme redesign dents confidence as rival readouts loom

Investors have not taken Halozyme’s news of a trial redesign well. A decision to drop a co-primary endpoint from the ongoing pivotal study of PEGPH20 in pancreatic cancer has been read as a bad omen, and shares in the company opened 11% lower this morning. Executives said it was taking longer than expected to accrue progression-free survival data – blaming more patients being lost to follow-up than expected – prompting the move to drop this as a co-primary endpoint. Survival data should emerge towards the end of 2019 and, while shareholders have to wait a bit longer, at least the readout will give a definitive answer on PEGPH20’s role in this disease. The study adds PEGPH20 to Abraxane and gemcitabine in front-line metastatic patients, and 8.5 months is the OS bar to beat; it is 93% powered to detect a hazard ratio of 0.67, which corresponds to a median OS benefit of 12.7 months versus 8.5 months. Hopes were already low for this project, given underwhelming mid-stage data, and this sort of move was never going to build confidence. And the bar could soon be rising, with important updates looming in pancreatic cancer, including a big readout early in the year from Astrazeneca and Merck & Co’s Parp inhibitor Lynparza in a maintenance setting.