41-15 Health Canada Approves New Indication for Xtandi

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Health Canada Approves New Indication for Xtandi

Health Canada approved a new indication for the use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.

The drug, sponsored by Astellas Pharma Canada Inc., was initially approved for use in patients with mCRPC who previously received docetaxel in the setting of medical or surgical castration.

This new approved use follows a Priority Review of the Supplementary New Drug Submission by Health Canada that was based on results of the phase III PREVAIL trial.

The trial was a randomized, placebo-controlled, multinational clinical trial that enrolled 1,717 chemotherapy-naïve patients with progressive metastatic prostate cancer who had failed ADT. The PREVAIL trial included thirteen Canadian trial sites including Kelowna, Vancouver, Victoria, Calgary, Edmonton, Winnipeg, London, Hamilton, Toronto, Ottawa, Montreal, Quebec City, and Halifax.

In the trial, men receiving enzalutamide therapy exhibited a statistically significant improvement in both overall survival and delayed time to radiographic progression or death as compared to those on placebo.

Specifically, enzalutamide significantly reduced the risk of radiographic progression or death by 81 percent compared with placebo (HR=0.19; p < 0.0001). Enzalutamide also significantly reduced the risk of death by 29 per cent compared with placebo (HR=0.71; p < 0.0001) and significantly delayed the start of chemotherapy by a median of 17 months compared with placebo (HR=0.35, p<0.001).

Bayer HealthCare expanded its global clinical development program for the investigational oncology compound copanlisib (BAY 80-6946), which now includes two new phase III studies in indolent non-Hodgkin’s lymphomas and one additional phase II study in diffuse large B-cell lymphoma.

Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase inhibitor with predominant inhibitory activity against both PI3K and PI3K isoforms. The PI3K pathway is one of the most frequently altered pathways in cancer and the PI3K isoforms trigger many cellular functions such as growth control, metabolism and transcription initiation.

The three studies will open for enrollment by mid-2015. Copanlisib was recently granted orphan drug designation by the FDA for investigation in follicular lymphoma.

CHRONOS-2 will be a phase III, randomized, double-blind, placebo-controlled study of copanlisib in rituximab refractory indolent NHL patients who have previously been treated with rituximab and alkylating agents (NCT02369016).

CHRONOS-3 will be a phase III, randomized, double-blind study evaluating the efficacy and safety of copanlisib in combination with rituximab versus rituximab monotherapy in patients with relapsed iNHL who have received at least one prior line of treatment, including rituximab and an alkylating agent (NCT02367040).

The phase II, open-label, single arm study will evaluate patients with relapsed or refractory DLBCL with copanlisib and assess the relationship between efficacy and potentially predictive biomarkers (NCT02391116).

Immunocore Ltd. and MedImmune, the global biologics research and development arm of AstraZeneca, entered into a second collaboration.

Immunocore will conduct a phase Ib/II clinical trial combining MedImmune’s investigational checkpoint inhibitors MEDI4736 (anti-PD-L1) and/or tremelimumab (anti-CTLA-4) with IMCgp100, Immunocore’s lead T-cell receptor based investigational therapeutic, for the potential treatment of patients with metastatic melanoma.

MedImmune has an exclusive relationship with Immunocore for the development of IMCgp100 in combination with MEDI4736 and/or tremelimumab, and will have first right of negotiation for the future commercial development of these combinations for tumors expressing gp100.

Immunocore and MedImmune will collaborate to establish a dosing regimen for IMCgp100 combined with MEDI4736 and/or tremelimumab, as part of the phase Ib study. The phase II study will assess the safety and efficacy of the different combinations.

The companies have a pre-existing research collaboration and licensing agreement, which began in January 2014, to develop novel cancer therapies using Immunocore’s Immune Mobilising Monoclonal T-Cell Receptor Against Cancer (ImmTAC) technology.


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