While AstraZeneca's AZN Imfinzi failed in a late-stage head & neck cancer study this week, Roche RHHBY gained FDA approval for a combination of its cancer drugs Tecentriq+Avastin for the first-line treatment of certain lung cancer patients. Eli Lilly LLY & Bristol Myers BMY signed new collaboration deals.
Recap of the Week's Most Important Stories
Lilly's New Alzheimer's Collaboration : Eli Lilly announced a collaboration agreement with Swiss biotech AC Immune to jointly develop Morphomer tau aggregation inhibitors , which have the potential to treat Alzheimer's disease (AD) and other neurodegenerative diseases. For the deal, Lilly will make an initial upfront payment of 80 Swiss francs to AC Immune and purchase $50 million note, convertible to equity position in AC Immune.
Meanwhile, the FDA granted fast track designation to Lilly's Olumiant (baricitinib) for the treatment of systemic lupus erythematosus (SLE). Lilly is evaluating two doses of baricitinib in phase III SLE studies. Olumiant is marketed for the rheumatoid arthritis indication globally.
AstraZeneca's Imfinzi Misses Endpoint in Head & Neck Cancer Study: AstraZeneca's phase III EAGLE study on its PD-L1 inhibitor, Imfinzi failed to meet primary endpoint of improvement in overall survival (OS). The study evaluated Imfinzi (durvalumab) as monotherapy as well as a combination therapy with tremelimumab for the treatment of advanced head-and-neck squamous cell carcinoma compared to chemotherapy ("HNSCC"). Imfinzi is presently approved for two cancer indications for unresectable, stage III NSCLC and metastatic urothelial carcinoma in second-line setting.
Roche's Tecentriq Gets FDA Nod for First-Line Lung Cancer: The FDA granted approval to Roche's PD-L1 inhibitor, Tecentriq for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in patients with no EGFR or ALK genomic tumor aberrations. The drug has been approved for use in combination with Avastin and chemotherapy. The approval was based on survival benefit observed in the phase III IMpower150 study. Sales of Tecentriq, already approved to treat certain types of lung cancer, rose 49% in the first nine months of 2018. The recent label expansion of the drug should further boost sales.
Bristol-Myers New Deal to Evaluate Opdivo Combo: Bristol-Myers announced a new clinical trial collaboration with Vedanta Biosciences to evaluate its PD-L1 inhibitor, Opdivo in combination with the latter's VE800 for advanced/metastatic cancers. Opdivo is a key drug in Bristol-Myers' portfolio, which is currently approved for several cancer indications. Bristol-Myers has collaboration agreements with several small and large biotech and pharma companies to evaluate Opdivo in combination with their cancer treatments.
J&J Presents Data from Tremfya Study: J&J JNJ announced data from phase III head-to-head study comparing the efficacy of its plaque psoriasis drug, Tremfya to market leader Novartis' Cosentyx. The data showed that after 48 weeks of treatment, 84.5% of the patients treated with Tremfya achieved 90% improvement in disease symptoms, as measured by the Psoriasis Area Severity Index, compared with 70% on Novartis's Cosentyx.
Novartis' Xolair Gets EU Nod for Self-Injection Option: The European Commission gave approval to Novartis' NVS Xolair prefilled syringe (PFS) for self administration in severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU). The Xolair PFS gives patients the option to self-inject or be injected by a trained caregiver, thereby decreasing the number of regular clinic visits and reduce the burden of such diseases.
The NYSE ARCA Pharmaceutical Index rose 1% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
While J&J and Glaxo recorded the highest gain (1.3%), Pfizer PFE declined the most (1%) in the last five trading sessions.
In the past six months, Lilly remains the biggest gainer (32.2%) while Glaxo declined the most (8.5%).
(See the last pharma stock roundup here: Glaxo's TESARO Buyout & Horlicks Sale, ASH Cancer Data Updates )
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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