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. 

Selected upcoming pancreatic cancer trial readouts 
Project Company Trial ID Outcome 
Phase III
Abraxane Celgene NCT01964430 (Apact) Completed recruitment, results expected early 2019
Lynparza Astrazeneca/Merck & Co NCT02184195 (Polo) Still recruiting, results expected H1 2019 (company guidance)
Imbruvica Johnson & Johnson/Abbvie NCT02436668 (Resolve) Completed recruitment, primary completion Aug 2018
PEGPH20 Halozyme Therapeutics NCT02715804 OS readout delayed to Q4 2019
Glufosfamide Eleison NCT01954992 Still recruiting, primary completion Jun 2019
AM0010 Lilly NCT02923921 (Sequoia) Second interim readout and final results expected 2020 (company guidance)
Napabucasin Sumitomo Dainippon NCT02993731  Recruitment ongoing, primary completion Dec 2020
Gemzar Unicancer consortium NCT02539537 (Neopan) Still recruiting, primary completion pushed out to Mar 2021
Pamrevlumab Fibrogen TBC  Phase III due to start early 2019
Phase II
BL-8040 +/- Keytruda Biolinerx/Merck & Co NCT02826486 Triple combo arm with chemo due to report end 2019
NANT Cancer Vaccine Nantkwest NCT03136406 Completed recruitment, results imminent? 

Source: Company statements, EvaluatePharma.

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