Results from the prematurely closed PledOx POLAR program
December 15, 2020
Stockholm, Sweden / Tokyo, Japan, December 15, 2020. PledPharma AB (“PledPharma”) (STO: PLED) and Solasia Pharma K.K. (“Solasia”) (TSE: 4597) today jointly announce that PledOx® did not meet the efficacy endpoint in the prematurely closed Phase 3 POLAR program. Based on further evaluation of the results from the POLAR studies, the strategic next steps for PledOx will be determined together with Solasia.
In the efficacy analysis, based on patient-reported symptoms of moderate or severe CIPN by the validated FACT/GOG-NTx instrument, combining data from both the POLAR-A study and the POLAR-M study, PledOx 5 μmol/kg in combination with chemotherapy did not reduce the risk of moderate to severe chemotherapy induced peripheral neuropathy (CIPN) at 9 months after the first cycle of chemotherapy versus chemotherapy alone.
The occurrence and type of adverse events observed were generally consistent with the expected toxicity caused by the chemotherapy and the patient populations studied. No negative effect on the anti-cancer effect of chemotherapy were observed with PledOx on progression-free survival (PFS), overall survival (OS) and disease-free survival (DFS), albeit based on a limited number of events. As previously identified by the independent drug safety monitoring board (DSMB) at the time when the POLAR program was prematurely stopped, an increased risk of allergic-hypersensitivity reactions was observed, with a small number of patients experiencing a serious adverse event (SAE) on PledOx in combination with chemotherapy. The severe allergic-hypersensitivity reactions occurred only after repeated treatment cycles.
Full results will be presented at a forthcoming scientific conference.
“The negative result in the efficacy analysis of the POLAR program is very disappointing, as we believe nerve damage associated with platinum-based chemotherapy is an important unmet medical need. Based on further evaluation of the results, we will conclude on the strategic next steps for PledOx together with Solasia. Our full focus is on building a specialized late-stage orphan drug development company with Emcitate® and Aladote® and their respective pivotal studies, as previously communicated”, said Nicklas Westerholm, Chief Executive Officer and President, PledPharma.
“We are disappointed that the efficacy endpoint for CIPN could not be achieved in the combined analysis of the POLAR M and POLAR A studies. Regarding future development strategies, we plan to evaluate and discuss the study results in detail with our partner PledPharma”. said Yoshihiro Arai, President and Chief Executive Officer, Solasia