Major news in the cancer segment this week was the failure of Eli Lilly and Company’s (LLY - Free Report) newly approved breast cancer drug Verzenio in a pivotal lung cancer study. With this latest failure, Lilly joins the list of large pharma companies who have failed in their respective lung cancer pivotal studies in the recent past. However, Verzenio was granted priority review status as first-line treatment for breast cancer.
Meanwhile, the FDA granted Breakthrough therapy designation to AstraZeneca PLC’s (AZN - Free Report) Tagrisso for EGFR mutation-positive non-small cell lung cancer (“NSCLC”) as well as Astellas’ leukemia candidate, gilteritinib. Also, AbbVie and Seattle Genetics announced collaboration agreements to strengthen their oncology pipeline.
Let’s see the news in details.
Eli Lilly and Company faced yet another pipeline setback as its phase III JUNIPER study failed to meet the primary endpoint of overall survival. The study was comparing Verzenio with Roche/Astellas Pharma’s Tarceva in patients with stage IV NSCLC who have KRAS mutation. Lilly announced that the FDA has granted priority review to the new drug application ("NDA") seeking approval as first-line treatment for advanced breast cancer. Verzenio was approved for treating metastatic breast cancer last month in patients where the disease progressed after platinum-based chemotherapy. (Read more:Verzenio Fails in Phase III Lung Cancer Study)
Eli Lilly and Company Price and Consensus
AstraZeneca’s Tagrisso was granted breakthrough therapy designation as first-line treatment for metastatic NSCLC with EGFR mutation this week. The company is developing the drug in a phase III study – FLAURA – comparing it against the standard-of care (“SOC”) EGFR tyrosine kinase inhibitor (“TKI”) therapy. Data from the study was presented earlier. AstraZeneca also announced that the European Medicines Agency has accepted its marketing authorization application (MAA) for Imfinzi for the treatment of locally-advanced unresectable non-small cell lung cancer.
Seattle Genetics, Inc. (SGEN - Free Report) along with its partner Astellas Pharma initiated a phase II study of enfortumab vedotinin locally advanced or metastatic urothelial cancer. Meanwhile, Seattle Genetics announced two clinical collaborations to evaluate SGN-LIV1A in triple negative breast cancer (“TNBC”). One study will evaluate SGN-LIV1A in combination with Merck and Co.’s (MRK - Free Report) Keytruda and the other study will evaluate the candidate in combination with standard chemotherapy as neoadjuvant treatment. (Read more: Seattle Genetics Inks Clinical Collaborations for Cancer Drug)
The week also saw an application submitted by Clovis Oncology (CLVS - Free Report) for the label expansion of Rubracaas a maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer. The FDA also granted Fast Track designation to expedite the development of Astellas Pharma’s gilteritinib in adult patients with relapsed or refractory acute myeloid leukemia who are FLT3 mutation-positive. Meanwhile, AbbVie (ABBV - Free Report) entered into a research, option and license agreement with Turnstone Biologics to gain rights to the latter’s next-generation oncolytic viral immunotherapies. The deal is expected to boost AbbVie’s immuno-oncology potential.
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