Additional data from EPIC-SR study for Paxlovid to support upcoming NDA submission to FDA.
Pfizer Inc. shared data from the Phase II/III EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study evaluating the use of Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) in patients who are at standard risk for developing severe COVID-19.
In previously reported interim analyses, the company disclosed that the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, and a non-significant 70% relative risk reduction was observed in the key secondary endpoint of hospitalization or death (treatment arm: 3/428; placebo: 10/426).An updated analysis from 1,153 patients enrolled through December 2021 showed a non-significant 51% relative risk reduction (treatment arm: 5/576; placebo: 10/569). A sub-group analysis of 721 vaccinated adults with at least one risk factor for progression to severe COVID-19 showed a non-significant 57% relative risk reduction in hospitalization or death (treatment arm: 3/361; placebo: 7/360).
Additional analyses of secondary endpoint data showed that treatment with Paxlovid resulted in a nominally significant 62% decrease in COVID-19-related medical visits per day across all patients, relative to placebo (p=0.0228). Types of medical visits included trips to the emergency room, urgent care, hospital admissions, and telehealth calls, among others. This observation is consistent with data from a secondary endpoint of the EPIC-HR1 study, which showed a 67% reduction in medical visits per day versus placebo (p<0.0001 statistically significant). an additional pre-specified descriptive analysis showed a 72% reduction in the average number of days in hospital among paxlovid-treated patients versus placebo in epic-sr. other not statistically significant findings included no paxlovid-treated patients admitted to the intensive care unit, compared to three in the placebo group, and no deaths in patients who received paxlovid with one death in the placebo group.
“Results from our Phase II/III EPIC-HR and EPIC-SR studies, as well as post-authorization experience, support the efficacy and safety profile for Paxlovid in the treatment of mild-to-moderate COVID-19 patients with at least one risk factor for progressing to severe COVID-19, regardless of vaccination status,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With up to 40-50% of people around the world estimated to be high risk, we believe there remains a significant unmet need for treatment options to help combat this disease, and we will continue to prioritize efforts to advance the development of Paxlovid.”
Treatment-emergent adverse events were comparable between Paxlovid (23.1%) and placebo (23.4%), most of which were mild in intensity. Rates of serious adverse events (1.4% vs. 1.9%) and discontinuation of study drug due to adverse events (1.7% vs. 1%) were also comparable between Paxlovid and placebo.
Due to a very low rate of hospitalization or death observed in the standard-risk patient population, Pfizer has decided to cease enrollment into EPIC-SR and include available data in this month’s planned New Drug Application (NDA) submission to the FDA)to support the use of Paxlovid in appropriate individuals at high risk of progression to severe illness. The company will focus efforts on generating further data on Paxlovid in vulnerable populations, including longer treatment durations in immunocompromised individuals, as well as exploring other clinical development opportunities, such as its potential use in hospitalized patients with severe disease.
Related news and insights
- Deciphera Pharmaceuticals, Inc. announced that the Journal of Clinical Oncology has published results from its INTRIGUE Phase III study of Qinlock (ripretinib) in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib.
Nature Medicine has published results from a prospective, open-label, single-arm, phase II TUXEDO-1 trial of Enhertu (trastuzumab deruxtecan), from Daiichi Sankyo + AstraZeneca, which enrolled patients aged at least 18 years with HER2-positive breast cancer and newly diagnosed untreated brain metastases or brain metastases progressing after previous local therapy, previous exposure to trastuzumab and pertuzumab and no indication for immediate local therapy
Biora Therapeutics, Inc. announced topline results from its recently completed study PM 602: A Scintigraphic Study to Evaluate the Localization and Delivery Function of a Drug Delivery System Capsule (DDS) in Subjects with Ulcerative Colitis in a Fasted State