Cancer, capable of striking fear in even the strongest of hearts, is a malignancy characterized by uncontrolled growth of abnormal cells, which, if not treated, can lead to death. According to the American Cancer Society, there are more than 100 types of cancers, the deadliest among them being breast cancer, skin cancer, lung cancer, colon cancer, prostate cancer, and blood cancer.
Presentations at the European Society for Medical Oncology ("ESMO") 2017 Congress held between Sep 8 and 12 in Madrid, Spain dominated headlines in the cancer space this week. Major presentations included Bristol-Myers Squibb Company (BMY - Free Report) and AstraZeneca, plc's (AZN - Free Report) positive results from ongoing phase III study in melanoma and lung cancer patients, respectively, and Pfizer, Inc.’s (PFE - Free Report) disappointing data for its lung cancer candidate.
Recap of the Week’s Most Important Stories
AstraZeneca’s Imfinzi Positive in Phase III Lung Cancer Study: AstraZeneca announced promising lung cancer data from a late stage study on its new cancer drug, Imfinzi. Interim data from the phase III study – PACIFIC – demonstrated that Imfinzi achieved an improvement of 11 months in progression-free survival over standard of care in patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) who have not progressed following chemoradiation. Data from a separate phase III FLAURA study on another lung cancer drug, Tagrisso, showed that the drug reduced the risk of progression or death by more than half compared with other commonly-used EGFR inhibitors. (Read more: AstraZeneca's Lung Cancer Study Data Promising)
Bristol-Myers’ Opdivo Superior to Yervoy in Melanoma Patients: Bristol-Myers announced data from a phase III study, CheckMate -238, comparing Opdivo to Yervoy for treating patients with stage IIIb/c or stage IV melanoma who have undergone complete resection. Interim data from the study showed that Opdivo is superior to Yervoy. Opdivo achieved a statistically significant improvement of 35% in recurrence-free survival compared to Yervoy. (Read more: Bristol-Myers Reports Positive Results from Melanoma Study)
Pfizer’s Xalkori Fails Lung Cancer Study/Xtandi Positive in Prostate Cancer Study: Pfizer’s ongoing phase III study (PROFILE 1014), evaluating Xalkori for the first-line treatment of ALK-positive NSCLC, did not meet its secondary endpoint of significant improvement in overall survival (OS) rates. After a median follow-up of 46 months, the median OS for patients treated with Xalkori was 45.8 months while it was 47.5 months for patients randomized to chemotherapy. However, Pfizer’s prostate cancer candidate, Xtandi achieved a statistically significant improvement in metastasis-free survival. The drug is being evaluated in combination with androgen deprivation therapy in a phase III study (PROSPER) for a potential label expansion to include early stage prostate cancer patients.(Read more: Pfizer Lung Cancer Drug's Overall Survival Data Unfavorable)
Disappointing Week for Roche: The FDA accepted Sandoz’s, the generics arm of Novartis, biologics license application for a biosimilar version of Roche’s (RHHBY - Free Report) leukemia treatment Rituxan (rituximab). Novartis has received approval for Rituxan’s biosimilar in Europe in June 2017. Rituxan had recorded sales of almost $3.9 billion in the first half of 2017. In another setback, the FDA approved Amgen/Allergan’s biosimilar version of another key drug, Avastin, for treating multiple cancer indications including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer. The biosimilar will be marketed by the trade name of Mvasi. (Read more: Novartis' BLA for Biosimilar of Rituxan Accepted by the FDA)
Apart from the abovementioned news, there were a few other updates in the cancer space. The FDA accepted two New Drug Applications (NDAs) of Array BioPharma seeking approval for the combination of binimetinib and encorafenib to treat patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The regulatory body also accepted a supplemental NDA for Teva Pharmaceutical Industries Ltd.’s (TEVA - Free Report) Trisenox seeking label expansion of the drug to include treatment naïve acute promyelocytic leukemia patients. Nektar Therapeutics announced the initiation of dosing in a phase I/II study, which evaluates the efficacy and safety of its lead immuno-oncology candidate, NKTR-214, in combination with Roche's Tecentriq and Merck's (MRK - Free Report) Keytruda.
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