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|
|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|
|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.