This week was ruled by cancer data presentations at the annual meeting of the American Society of Clinical Oncology (“ASCO”) in Chicago by pharma bigwigs like Bristol Myers (BMY - Free Report) , Merck (MRK - Free Report) and Roche (RHHBY - Free Report) , among others. JAK inhibitors were in the news this week with Lilly (LLY - Free Report) finally gaining FDA approval for its rheumatoid arthritis (“RA”) candidate Olumiant (baricitinib) in the United States while AbbVie (ABBV - Free Report) presented positive top-line data from its fifth late-stage study on upadacitinib in RA.
Recap of the Week’s Most Important Stories
Update from ASCO: Merck stole the show at ASCO after presenting data from several cancer studies of its PD-L1 inhibitor, Keytruda. Key presentations were from two pivotal lung cancer trials. KEYNOTE-042 study evaluated Keytruda monotherapy in newly-diagnosed lung cancer patients while KEYNOTE-407 study evaluated Keytruda in combination with chemotherapy in difficult-to treat squamous non-small cell lung cancer (NSCLC). Both the studies showed that treatment with Keytruda led to improved survival. Particularly, data from the KEYNOTE- 407 study, which evaluated Keytruda in combination with chemotherapy for the first-line treatment of metastatic squamous NSCLC was considered “practice changing” by investors.
Four and five years follow-up data presented from two advanced melanoma studies showed that treatment with Keytruda led to long-term survival benefit. Interim data from a cohort of a phase II study, KEYNOTE-158, evaluating Keytruda as a monotherapy in patients with previously treated advanced small cell lung cancer (SCLC) demonstrated encouraging response rates in the overall population of SCLC patients as well as in patients whose tumors express PD-L1. Keytruda also demonstrated encouraging ORR in studies evaluating the Lenvima/Keytruda combination in four different tumor types and Keytruda monotherapy for the first-line treatment of advanced clear cell RCC.
Bristol-Myers and Nektar Therapeutics (NKTR) presented preliminary data from a mid-stage study evaluating NKTR-214 in combination with Bristol-Myers’PD-L1 inhibitor, Opdivo in several tumor types. The response rates in melanoma and kidney cancer patients did not impress investors, resulting in a 42% drop in Nektar’s stock on Monday. (Read more: Nektar and Bristol-Myers Present Data on Cancer Study)
Bristol-Myers also presented data on Opdivo at ASCO. In a late-stage study evaluating Opdivo versus Yervoy in a broad range of patients with resected stage III or IV melanoma, Opdivo demonstrated sustained, superior recurrence-free survival versus Yervoy. In another study, Opdivo plus chemotherapy showed improved PFS versus chemotherapy in first-line lung cancer patients with PD-L1 expression <1%.
Novartis (NVS) announced positive data from a combination study on breast cancer drug Kisqali and from two long-term leukemia studies on Tasigna. (Read more: Novartis Announces Positive Data on Kisqali and Tasigna).
Roche presented data from a late-stage study, which showed that Tecentriq (atezolizumab) plus chemotherapy reduced the risk of disease worsening or death (PFS) by 29% in advanced squamous NSCLC patients versus chemotherapy alone.
AbbVie presented early data from a phase II study evaluating a combination of its cancer drugs Imbruvica plus Venclexta (venetoclax) for the first-line treatment of patients with chronic lymphocytic leukemia (CLL). The data demonstrated high rates of responses in such patients. Also, interim data from a late-stage study evaluating Imbruvica plus Roche’s Rituxan in Waldenström’s macroglobulinemia, a rare form of Non-Hodgkin’s lymphoma, showed that the combination significantly reduced the risk of disease progression or death by 80% compared to placebo plus Rituxan.
Pfizer (PFE - Free Report) , AstraZeneca and J&J also made some cancer data presentations at the meeting.
Lilly Gets FDA Nod for Lower Dose of Olumiant: Eli Lilly and partner Incyte gained FDA approval for the lower dose of (2 mg) of the companies’ JAK inhibitor, Olumiant. The FDA did not approve the higher dose (4 mg) and the drug’s label was approved with a boxed warning stating risk of serious infections, malignancies and thrombosis. Olumiant is already marketed in Europe and Japan and generated sales of $32.2 million in the first quarter of 2018. In the United States, Lilly faced significant trouble in getting FDA nod for Olumiant. In April last year, the FDA had issued a complete response letter for the new drug application seeking approval of Olumiant, requesting additional information to determine the most appropriate doses. This year in April, an FDA advisory committee had recommended approval of the lower dose of the drug while not recommending the higher dose of 4 mg on inadequate safety profile to support an approval relative to its benefits. (Read more: Eli Lilly's Olumiant Gets FDA Nod for Rheumatoid Arthritis).
AbbVie’s 5th Late-Stage Upadacitinib Study Succeeds: AbbVie’s oral JAK-1 selective inhibitor, upadacitinib, met all primary as well as secondary endpoints in the fifth phase III study from its SELECT program. Top-line data from the study showed thata significantly higher proportion of patients treated with upadacitinib in both 15 and 30 mg doses achieved superior responses compared to chemotherapy agent methotrexate. AbbVie plans to submit regulatory applications for upadacitinib in rheumatoid arthritis in the second half of the year. (Read more: Abbvie’s Upadacitinib Fifth RA Study Data Positive)
Allergan Under Activist Pressure to Split CEO-Chairman Roles: Allergan (AGN - Free Report) was under pressure this week after two hedge-fund firms, Senator Investment Group and Appaloosa, disclosed a letter urging the company to engage in a management and board overhaul. The firms asked the pharmaceutical company to split its chairman and chief executive roles, both presently held by Brent Saunders, among other management changes. Appaloosa run by David Tepper and Senator Investment Group run by Douglas Silverman, suggested an outsider should be hired for either of the roles. The letter comes on the heels of Allergan’s strategic plan announced last week to divest its women's health and infectious disease units. Allergan responded by saying that the board has been refreshed with the addition of three members in the last 16 months. (Read more: Allergan Requests Shareholders to Veto Management Change).
Glaxo Completes Buyout of Novartis’ Stake in Consumer Healthcare JV: Glaxo announced that it has completed its previously announced deal to buy out Novartis’ 36.5% stake in the Consumer HealthCare joint venture for $13 billion (£9.2 billion),
With the acquisition of Novartis’ stake, Glaxo now has 100% ownership of its Consumer Healthcare unit, which includes products such as Sensodyne and Flonase. Glaxo and Novartis created the JV in 2015 as part of a three-part transaction between the two companies by combining their consumer divisions.
Pfizer to Invest More in Venture Capital Arm: : Pfizer plans to invest $600 million in its venture capital arm, Pfizer Ventures which will be invested in small biotechs and other emerging growth companies. About 150 million will be earmarked for companies involved in promising early-stage neuroscience research. (Read more: Pfizer Boosts Venture Capital Efforts, Neuroscience in Focus)
Meanwhile, Pfizer’s regulatory applications for orally-available PARP inhibitor, talazoparib, for metastatic breast cancer patients with an inherited BRCA mutation, were accepted for review by the FDA and the European Medicines Agency. In the United States, the new drug application (NDA) was granted priority review by the FDA with a decision accepted in December this year.
Top-line results from talazoparib’s registrational study, EMBRACA, in germline-BRCA mutated breast cancer, presented in December 2017 demonstrated superiority of talazoparib over chemotherapy in improving progression free survival.
Roche’s Haemophilia A Candidate Gets Priority Review: Roche’s sBLA looking for label expansion of its drug, Hemlibra for people with haemophilia A without factor VIII inhibitors was granted priority review by the FDA. Hemlibra is presently marketed for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia A patients with factor VIII inhibitors. With the FDA granting priority review, a decision is expected on Oct 14
Separately, Roche’s cancer drug Rituxan gained FDA approval for a new indication, moderate to severe pemphigus vulgaris (PV), a potentially life-threatening disease
The NYSE ARCA Pharmaceutical Index rose 1.7% 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 last week except AstraZeneca, which declined 1.8%. Merck rose the most (4.2%) on ASCO strength.
In the past six months, Glaxo (GSK) has been the biggest gainer (15.4%) while Bristol Myers declined the most (16.5%).
(See the last pharma stock roundup here: Pharma Stock Roundup: Zoetis to Buy Abaxis, NVS Gets FDA Nod for Migraine Drug)
What's Next in the Pharma World?
Watch out for FDA decisions on many pipeline drugs and line extensions of marketed products this month.
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