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. In other news, Lilly’s (LLY - Free Report) new migraine drug, Emgality and Merck’s antibacterial medicine Zerbaxa were approved by the FDA for new indications.
Recap of the Week’s Most Important Stories
Update from ASCO: Merck presented data from several cancer studies of its PD-L1 inhibitor, Keytruda and PARP inhibitor, Lynparza.
It presented follow-up data from lung cancer studies on Keytruda. Data from the phase Ib KEYNOTE-001 study (n=550) showed that five-year overall survival (OS) rates for Keytruda were 23.2% in treatment-naïve lung cancer patients and 15.5% in previously treated lung cancer patients. Historically, the five-year survival rate in advanced lung cancer patients in the United States has been around 5%. Keytruda’s five-year survival rates thus represent a huge improvement over these historical rates. Follow up lung cancer data from the KEYNOTE-189 study showed that Keytruda in combination with Lilly’s Alimta (pemetrexed) and platinum chemotherapy reduced the risk of death by 44% compared with chemotherapy alone as a first-line treatment option for metastatic non-squamous non-small cell lung cancer (NSCLC) in patients with no EGFR or ALK genomic tumor aberrations.
Merck and partner AstraZeneca (AZN - Free Report) announced detailed data from the phase III POLO study evaluating Lynparza for germline BRCA-mutated metastatic pancreatic cancer patients who did not progress on chemotherapy. The data showed that at six months, more than twice as many patients being treated with Lynparza were progression free compared to those on placebo. Lynparza reduced the risk of disease progression or death by 47%. Full data presented from phase III SOLO 3 study on Lynparza in advanced ovarian cancer demonstrated a 72% objective response rate compared to 51% in patients receiving chemotherapy
Bristol-Myers presented data from multiple studies on its PD-L1 inhibitor, Opdivo, at ASCO including the longest follow-up data for the Opdivo plus Yervoy combination in advanced melanoma patients. A five-year analysis of the phase I CA209-004 study showed that overall survival (OS) rates were stable at 57% in the Opdivo plus Yervoy arm, with a median follow-up of 43.1 months in all patients, at four years or longer. Moreover, data presented from multiple analyses of CheckMate - 067 study demonstrated that the quality of life was maintained throughout the course of Opdivo plus Yervoy treatment and follow-up. These data clearly reinforce the long-term efficacy of the combination treatment in advanced melanoma.
AstraZeneca presented three-year overall survival (OS) results from a lung cancer study on Imfinzi. Sanofi’s (SNY - Free Report) phase III data on its investigational anti-CD38 monoclonal antibody isatuximab showed that the candidate in combination with pomalidomide and dexamethasone led to an impressive 40% reduction in the risk of disease progression or death for patients with relapsed/refractory multiple myeloma. J&J (JNJ - Free Report) presented long-term data from two pivotal studies on Imbruvica and from a couple of studies on Darzalex.
Novartis, Bayer and Roche also made some cancer data presentations at the meeting.
FDA Grants Approval to Lilly’s Emgality for Cluster Headache: The FDA granted approval to Lilly’s CGRP antibody, Emgality injection (300 mg) for the preventive treatment of episodic cluster headache in adult patients. Emgality is now the only CGRP antibody approved for two headache disorders— migraine and episodic cluster headache. Emgality was launched for preventive treatment of migraine last year along with two other CGRP antibodies, Amgen and Novartis’ Aimovig and Teva’s Ajovy. The approval for this expanded patient population gives Lilly’s Emgality an edge over the other two CGRP pain medications.
FDA Ok’s Expanded Use of Merck’s Zerbaxa: The FDA granted approval to Merck’s antibacterial medicine, Zerbaxa for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). Zerbaxa, a combination of ceftolozane and tazobactam, is presently marketed for some complicated urinary tract infections.
AstraZeneca’s Calquence Improves Survival in 2nd CLL Study: AstraZeneca’s phase III study evaluating Calquence combination compared to standard-of-care medicines for previously-untreated chronic lymphocytic leukaemia (CLL) met the primary endpoint. Interim data from the ELEVATE-TN study showed that treatment with Calquence in combination with obinutuzumab led to statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) — the primary endpoint — compared with chemotherapy-based combination of chlorambucil and obinutuzumab.
This is the second CLL study on Calquence to have met the primary endpoint. In May, AstraZeneca announced positive results from the ASCEND study evaluating Calquence in relapsed/recurrent disease setting. Calquence is presently marketed for the treatment of relapsed or refractory mantle cell lymphoma (MCL). It is being developed in phase III studies for the larger CLLindication and AstraZeneca expects to file regulatory applications based on data from the ASCEND and ELEVATE-TN studies later this year and get approval for CLL
FDA and CHMP Nod to At-home Administration Options for Glaxo’s Nucala: The FDA granted approval to two new self-administered options for Glaxo’s asthma drug Nucala, an autoinjector and a pre-filled safety syringe, to be taken once every four weeks.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) also issued a positive opinion recommending approval for the two new self-administered options, a pre-filled pen and a pre-filled safety syringe, to be taken once every four weeks
The NYSE ARCA Pharmaceutical Index rose 2.45% in the last five trading sessions.
Last week, all the stocks were in the green with J&J gaining the most (4.2%).
In the past six months, Merck has been the biggest gainer (5.2%) while Bristol-Myers declined the most (12.2%).
(See the last pharma stock roundup here: MRK's Cancer Biotech Buyout, ABBV, LLY's Pipeline Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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