This week Merck’s (MRK - Free Report) PD-L1 inhibitor, Keytruda was in the limelight as it gained EU approval as a combination therapy for the first-line treatment of advanced lung cancer. AstraZeneca (AZN - Free Report) gained FDA approval for Lumoxiti, its treatment for hairy cell leukemia (“HCL”), a rare type of blood cancer. The regulatory agency however rejected Glaxo’s (GSK - Free Report) application for label expansion of its asthma drug, Nucala for a new indication – COPD. Pfizer (PFE - Free Report) and Bristol-Myers (BMY - Free Report) announced successful study data.
Recap of the Week’s Most Important Stories
Merck’s Keytruda in Focus: Merck announced that the European Commission has granted approval to Keytruda in combination with chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). Based on significant survival benefit demonstrated in a key late-stage lung cancer study, KEYNOTE-189, Keytruda is now approved in EU for use in combination with Lilly’s (LLY - Free Report) Alimta (pemetrexed) and platinum chemotherapy (cisplatin or carboplatin) for the said indication regardless of PD-L1 expression. In Europe, Keytruda is already approved as a monotherapy for first-line NSCLC. With the latest approval, it is approved both as a monotherapy as well as a combination therapy for first-line NSCLC treatment.
Notably, in May 2017, this combination therapy was granted accelerated approval in the United States by the FDA for the aforementioned indication. The approval was based on tumor response rate and PFS data from the phase II KEYNOTE-021 study. The positive readouts from the KEYNOTE-189 confirmatory study helped the company get the accelerated approval converted to a continued approval in August 2018.
The FDA granted priority review to Merck’s supplemental biologics license application (sBLA) to include overall survival data from a key lung cancer study, KEYNOTE-042 study, on the label of Keytruda. If the OS data from KEYNOTE-042 study are approved to be included in Keytruda’s label, the drug can be prescribed to treat an expanded lung cancer patient population. With the FDA granting priority review, a decision is expected on Jan 11, 2019.
Meanwhile, Merck’s antibiotic Zerbaxa (a combination of ceftolozane and tazobactam) succeeded in a late-stage study evaluating it for either ventilated hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). Zerbaxa is presently marketed for some complicated urinary tract infections. The pivotal phase III study demonstrated non-inferiority of Zerbaxa to meropenem, the active comparator, thereby meeting the study’s primary endpoint. Based on these data, Merck plans to submit regulatory applications in the United States and EU to get approval for the new indication.
AstraZeneca Gets FDA Nod for Rare Blood Cancer Drug: The FDA granted approval to AstraZeneca’sBLA seeking approval of moxetumomab pasudotox for the second or later-line treatment of HCL. The leukemia drug will be marketed by the trade name of Lumoxiti.
Glaxo Nucala Gets Rejected for COPD Indication: The FDA issued a complete response letter to Glaxo’s application for label expansion of its asthma drug, Nucala for a new indication — eosinophilic chronic obstructive pulmonary disease (COPD). The CRL was not exactly a surprise as in July an FDA advisory committee had voted against recommending approval of Nucala for COPD. (Read more: Glaxo’s Nucala Suffers Regulatory Setback, Gets CRL for COPD)
Pfizer’s Bavencio + Inlyta Combo Improves PFS in Kidney Cancer: Pfizer’s phase III study on a combination of its cancer drugs, Bavencio and Inlyta, met the primary endpoint of improving progression-free survival (PFS) with statistical significance in advanced kidney cancer patients with PD-L1+ tumors. An independent Data Monitoring Committee confirmed the results as part of a planned interim analysis. Based on the interim results for PFS, Pfizer and its partner Merck KGaA will file regulatory applications in the United States. (Read more: Pfizer’s Drug Combo Betters Survival in Kidney Cancer Study)
Bristol-Myers Shows Promise in Phase II Psoriasis Study: Bristol-Myers announced that its pipeline candidate BMS-986165 achieved significant skin clearance and improvements in quality of life measures, in patients with moderate to severe plaque psoriasis in a phase II study. The data demonstrated that following 12 weeks of treatment with this novel, oral, selective TYK2 inhibitor, 67%-75% patients achieved the efficacy endpoint of ≥75% reduction in the Psoriasis Area and Severity Index (PASI 75) versus 7% for placebo. (Read more:Bristol-Myers Reports Phase II Data on Psoriasis Drug)
Lilly Initiates New Study on Taltz: Lilly announced the initiation of a head-to-head study to evaluate superiority of its plaque psoriasis drug, Taltz over J&J’s (JNJ - Free Report) new drug, Tremfya (guselkumab). The primary endpoint of the study — IXORA-R — will be the proportion of patients who achieve complete skin clearance, in other words, 100% improvement from their baseline as measured by PASI 100 score. The study is expected to be completed by the end of next year.
FDA Grants Priority Review to Sanofi’s Praluent sBLA: Sanofi along with partner Regeneron said the FDA has granted priority review to its sBLA seeking approval to include data from the phase III cardiovascular outcome study (ODYSSEY OUTCOMES) on the label of its anti PCSK9 therapy, Praluent Injection. The FDA will give its decision on Apr 28, 2019.
The study evaluated Praluent as a potential treatment to reduce major adverse cardiovascular events like heart attack, ischemic stroke, death from coronary heart disease and unstable angina requiring hospitalization. Though Praluent was approved by the FDA in 2015, its sales are yet to pick up. Significant payer utilization management restrictions in the United States and limited market access in Europe have been hurting sales of Praluent. Inclusion of phase III cardiovascular outcome study data on the label can improve the drug’s uptake.
The NYSE ARCA Pharmaceutical Index rose 2.2% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
All stocks were in the green this week except Glaxo and Bristol-Myers. Glaxo declined the most (1.1%) while Pfizer recorded the highest gain of 2.5% in the last five trading sessions.
In the past six months, Lilly remains the biggest gainer (35.4%) while Bristol-Myers declined the most (8.2%).
(See the last pharma stock roundup here: NVS’ Sandoz Deal, Pipeline Updates at AZN & Others in Focus
What's Next in the Pharma World?
Watch out for several pipeline and regulatory updates next week
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