Phase III trial of Kadcyla shows benefits in Breast Cancer
Results from TH3RESA, a Phase III clinical trial of Kadcyla (ado trastuzumab emtansine), also known as T-DM1, from Genentech/Roche, show that it significantly improves the length of time before the disease worsens in women with advanced HER2 positive Breast Cancer whose disease has recurred or progressed despite previous treatments. Results showed that median progression-free survival increased by nearly three months from 3.3 months for the conventionally treated patients to 6.2 months for patients receiving Kadcyla. Among the Kadcyla patients, 31.3% showed a response to the drug, compared with 8.6% with conventional treatments.
An interim analysis of overall patient survival showed a similar trend, but it did not reach the level at which a statistically significant benefit for Kadcyla treatment could be confirmed. Generally, there were fewer serious adverse side-effects in the Kadcyla patients than in the control group. Data was presented by Professor Hans Wildiers at the 2013 European Cancer Congress.
Related news and insights
Eli Lilly and Company and Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant (baricitinib) for the treatment of adults with severe alopecia areata (AA).
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has approved Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg.
Mirati Therapeutics announced that it has submitted a Marketing Authorization Application to the European Medicines Agency for MRTX 849 (adagrasib) for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy.