The late-stage pancreatic pipeline thins again as Halozyme falls

The failure of Halozyme’s PEGPH20 to show any benefit in a phase III pancreatic cancer study marks the fourth big setback for this field this year. The drug joins J&J’s Imbruvica, Sumitomo Dainippon’s napabucasin and Eli Lilly’s pegilodecakin, all failures at the pivotal stage. Hopes had dimmed for PEGPH20 after Halozyme changed the trial design last year, but confirmation is still disappointing in a disease that desperately needs to find a way forward. Astrazeneca and Merck are waiting to find out whether the FDA will grant approval to Lynparza before the end of the year, but even if it does the Parp inhibitor will only be available to BRCA-positive patients and, after failing to detect an overall survival benefit, a green light is far from certain. Next year should see final and interim readouts from AB Science, Erytech and Rafael, though with those projects in the hands of small drug developers an even bigger handicap should probably be applied to success. The most closely-watched project for many investors is Fibrogen’s pamrevlumab, although results from its phase III trial are some time away. All of which means the earlier-stage pipeline is probably the place to search for glimmers of hope in this tumour type.

Selected late stage pancreatic cancer trials 
Project Company Setting  Trial ID Outcome
Lynparza Astrazeneca/Merck & Co BRCA+, maintenance (Responders to 1st-line platinum chemo) NCT02184195
(Polo)
Met PFS but missed OS. Filed with US decision due Q4'19.
Masican (masitinib) AB Science 1st-line, non resectable locally advanced or metastatic patients with pain NCT03766295/
2013-002293-41
IDMC recommended trial continue in pre-defined sub-group only; final data due 2020
Nanoplatin (demplatin pegraglumer) Orient Europharma/Nanocarrier 1st-line, locally advanced or metastatic NCT02043288/
JapicCTI-173620
Results due H1 2020 (trial in Asia only)
Graspa (eryaspase) Erytech Pharma Second-line, stage III or IV  NCT03665441
(Trybeca-1)
Interim analysis due Q3'20, primary completion Nov 2020
SM-88 (racemetyrosine) Tyme Technologies 3rd-line, metastatic  NCT03512756
(Tyme-88-Panc)
Enrollment in pivotal portion due to begin Q4 2019
CPI-613 (devimistat) Rafael Pharmaceuticals 1st-line metastatic NCT03504423
(Avenger 500)
Interim analysis due before Q2'20. Primary completion Oct 2021
Glufosfamide Eleison Second-line metastatic NCT01954992 Primary completion Mar 2021
Pamrevlumab Fibrogen 1st-line, locally advanced NCT03941093
(Lapis)
Primary completion Sep 2022
Source: EvaluatePharma, Clinicaltrials.gov

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