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Pharma Notes
Health Canada has approved KADCYLA (trastuzumabemtansine or T-DM1), under priority review, as a single agent for the treatment of people with HER2-positive metastatic breast cancer (mBC) who received both prior treatment with HERCEPTIN® (trastuzumab) and a taxane, separately or in combination. Developed by F.
Hoffmann-La Roche Ltd./
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Roche Canada (Mississauga, ON) KADCYLA is a fi rst in class antibody-drug conjugate (ADC) and is made up of three components, an approved monoclonal antibody known as HERCEPTIN (trastuzumab), a stable linker and a potent cytotoxic agent known as DM1. KADCYLA targets cancer cells that overexpress the HER2 receptor and, via two distinct mechanisms, results in cell cycle arrest or death of cancer cells. The Health Canada approval of KADCYLA is based on results from the EMILIA Study, an open-label, international, and randomized Phase 3 study comparing KADCYLA to lapatinib in combination with XELODA® (capecitabine), one of the standard treatment options in this setting. EMILIA assessed 991 randomly assigned patients with HER2positive locally advanced or metastatic breast cancer who had previously been treated with HERCEPTIN and a taxane chemotherapy.
Oncolytics Biotech Inc.
(Calgary, AB) has released fi nal tumour response data from its U.S. Phase 2 single arm clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel (REO 021). The analysis examined per cent best overall tumour responses between pre-treatment and up to six treatment cycles. Of 25 evaluable patients who had more than one cycle of therapy, 23 (92%) exhibited overall tumour shrinkage (mean shrinkage was 32.7%). Of the 25 evaluable patients, 10 (40%) had partial responses (PRs), while a further 13 (52%) showed stable disease (SD) and two (8%), had progressive disease (PD), for a disease control rate (complete response (CR) + PR + SD) of 92%. The study enrolled patients with metastatic stage IIIB or stage IV, or recurrent, squamous cell carcinoma of the lung, who were chemotherapynaïve for their metastatic or recurrent cancer. The primary objective of the trial is to evaluate the patients’ tumour response. The secondary objectives are to assess progression-free survival and overall survival for the treatment regimen in the study population; to determine the proportion of patients receiving the above treatment who were alive and free of disease progression at six months; and to assess the safety and tolerability of the treatment regimen in the study population. Final progression-free survival and safety data for the study will be reported later in 2013.
Almirall, a pharmaceutical company based in Barcelona, Spain, has launched a new affi liate in Canada. The Canadian affi liate will focus primarily on the respiratory and dermatology therapeutic areas. Based in Mississauga, the new affi liate will support the Canadian launches of new Almirall products including an innovative new treatment for chronic obstructive pulmonary disease (COPD), Tudorza™/Genuair™, which will launch in the fall. Almirall Canada is the company’s 13th affi liate joining affi liates across Europe and Mexico
Transition Therapeu-
tics Inc. (Toronto, ON) has dosed its fi rst patient in its Phase 2a study of ELND005 in Down syndrome. Study ELND005-DS201 will evaluate the safety and pharmacokinetics of two doses of ELND005 and placebo in young adults with Down syndrome without dementia, and will also include select cognitive and behavioural measures. Information on the study design and protocol for ELND005-DS201 can be found at http://clinicaltrials.gov/. The fi rst person was dosed at the site of Dr. Ira Lott, professor of Neurology and Pediatrics and Down syndrome expert at the University of California, Irvine.
DelMar Pharmaceu-
ticals, Inc. (Vancouver, BC) and Guangxi Wuzhou
PharmaceuticalCo. Ltd.
have established a clinical advisory board to oversee new clinical studies aimed at expanding the market opportunity for VAL-083, known as “DAG for Injection” in China. DelMar and Guangxi Wuzhou Pharmaceutical established a collaboration and exclusive supply agreement in 2012. Under the terms of the collaboration, the companies are working together to ensure the product specifi cations meet global standards in order to accelerate international development and regulatory approval for VAL-083 on a worldwide basis. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. DelMar is currently conducting a Phase 1/2 doseescalation study in the U.S. designed to assess the safety and effi cacy of VAL-083 as a potential treatment for patients suffering from refractory glioblastomamultiforme (GBM), the most common and aggressive form of brain cancer, who have failed standard therapies and have no viable treatment options. DelMar and Guangxi Wuzhou Pharmaceutical have nominated physicians as an initial advisory board to provide oversight and design of clinical trials to be conducted in accordance with the terms of the collaboration agreement.
OncoGenex Pharmaceu-
ticals, Inc. (Vancouver, BC) has completed enrollment in its Borealis-1™ randomized, placebo-controlled Phase 2 trial of OGX-427 in combination with fi rst-line gemcitabine and cisplatin in patients with metastatic bladder cancer. Approximately 180 patients have been randomized into Borealis-1 at 55 clinical sites throughout North America and Europe. The three-arm trial randomized patients to receive gemcitabine, cisplatin, and OGX-427 at two dose-levels (600 mg or 1000 mg) vs. gemcitabine, cisplatin, and placebo. The primary endpoint of the trial is overall survival. Additional analyses will be conducted to evaluate benefi t/ risk of the two dosing levels using clinical benefi t, safety and tolerability outcomes for each dose level. Borealis-1 is one of two ongoing clinical trials of OGX-427 in metastatic bladder cancer. The Borealis-2™ trial is an investigator-sponsored, randomized Phase 2 trial evaluating OGX-427 in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following fi rst-line platinum-based chemotherapy. This trial is sponsored by the Hoosier Oncology Group and currently enrolling patients.
