Bristol-Myers Squibb announced significant recurrence-free survival results from an ongoing Phase III study evaluating (Opdivo) nivolumab versus ipilimumab in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma. In the study (involving 906 patients), treatment with nivolumab resulted in significant improvement of 35% (HR 0.65; 97.56% CI: 0.51 to 0.83; p <0.0001) in RFS (length of time after initial treatment with no sign of the cancer returning) compared with ipilimumab. The 18-month RFS rate for nivolumab was 66% (95% CI: 61.8 to 70.6), compared to 53% (95% CI: 47.8 to 57.4) in patients treated with ipilimumab.
ERYTECH Pharma, a clinical-stage biopharmaceutical company developing therapies by encapsulating therapeutic drug substances inside red blood cells, announced the presentation of the full data from its Phase 2b study evaluating eryaspase (GRASPA) in combination with chemotherapy for the treatment of metastatic pancreatic cancer. The study met its co-primary endpoints of OS and PFS with Hazard Ratios (HR) below 0.85 in patients with no or low asparagine synthetase expression (ASNS 0/1), approximately 70% of the study population, and demonstrated statistically significant improvements of OS and PFS in the entire patient population.
Pfizer announced positive findings from REFLECTIONS B327-02, a pivotal Phase III study of the company’s investigational Herceptin (trastuzumab) biosimilar versus Herceptin, at the European Society for Me dical Oncology (ESMO) 2017 Congress in Madrid. The study found there were no clinically meaningful differences between the biosimilar and Herceptin in terms of efficacy, safety, immunogenicity, and noninferiority in pharmacokinetics, as neoadjuvant treatment taken in combination with docetaxel and carboplatin for patients with operable HER2-positive breast cancer.