This week was a relatively busy one for the pharma sector, marked by earnings of bigwigs like Merck (MRK - Free Report) and Bristol Myers (BMY - Free Report) . Early this week, several drug giants presented data from key cancer studies at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich, Germany.
Recap of the Week’s Most Important Stories
Merck & Bristol-Myers Announce Mixed Quarterly Results: Both Merck and Bristol-Myers’ third-quarter results were mixed as the companies beat estimates for earnings but slightly missed the same for sales. Though Merck tightened its sales guidance for 2018, it was only due to less favorable currency impact owing to a strengthening dollar. It raised its expectations for adjusted earnings for the full year. Bristol-Myers also increased its adjusted earnings guidance for 2018 while raising sales growth expectations for the full year.
Earlier in the week, Merck announced that it received positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for label expansion of its PD-L1 inhibitor, Keytruda as an adjuvant therapy in patients with stage III melanoma who have undergone surgery.
Cancer Data at ESMO: Merck and partner AstraZeneca (AZN - Free Report) presented data from a phase III SOLO-1 study, which showed that its key cancer drug Lynparza, as a maintenance therapy, cut the risk of disease progression or death by 70% in patients with newly-diagnosed, advanced BRCA-mutated ovarian cancer. Meanwhile, 60.4% of patients treated with Lynparza remained progression-free at 36 months compared with 26.9% of those in the placebo arm.
Merck also presented interim data from the KEYNOTE-057 study on Keytruda in patients with high-risk non-muscle invasive bladder cancer (NMIBC), which was unresponsive to standard of care. In the study, Keytruda led to a complete response rate of nearly 40%. Merck also presented interim data from the phase III KEYNOTE-048 study evaluating Keytruda, both as a monotherapy and in combination with chemotherapy, for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The data showed that Keytruda monotherapy improved overall survival by 39% and 22%, respectively in patients whose tumors expressed PD-L1 with CPS≥20 and CPS≥1. Meanwhile, as a combination regimen, it improved OS by 23% in the total patient population.
Novartis (NVS - Free Report) presented data from a phase III study evaluating its investigational treatment BYL719 (alpelisib) plus fulvestrant for the treatment of patients with HR+ advanced breast cancer whose disease has progressed on or after an aromatase inhibitor with or without a CDK4/6 inhibitor versus fulvestrant alone. In the study, BYL719 plus fulvestrant demonstrated a median progression-free survival (PFS) of 11 months compared to 5.7 months for fulvestrant alone and reduced the risk of death or progression in those patients by an estimated 35% compared to fulvestrant alone. Novartis also presented positive data from a mid-stage study on its pipeline candidate, capmatinib in patients with MET mutated advanced non-squamous non-small cell lung cancer (NSCLC).
Roche presented data from pivotal mid-stage/early-stage studies, which showed that its investigational personalized medicine entrectinib shrank tumors in 57.4% of patients with NTRK fusion-positive solid tumour. Importantly, entrectinib shrank tumors irrespective of tumor type even those that had spread to the brain, thus demonstrating the candidate’s potential to treat a range of difficult-to-treat and rare cancers.
Separately, Roche also presented data, which showed that its breast cancer treatment, Tecentriq in combination with Abraxane significantly improved progression-free survival compared with chemotherapy alone as a first-line treatment for patients with metastatic triple-negative breast cancer who had high levels of a protein known as PD-L1. Another phase III data on Tecentriq showed that the drug in combination chemotherapy, as an initial treatment, helped advanced NSCLC patients, live significantly longer compared to chemotherapy alone
Bristol-Myers also presented data from several cancer studies, which demonstrated survival benefits and encouraging response rates of the combination regimen of its drugs Opdivo plus Yervoy. Pfizer (PFE - Free Report) presented detailed overall survival data from the phase III PALOMA-3 study evaluating a combination of its breast cancer drug, Ibrance and AstraZeneca’s Faslodex in women with HR+, HER2- metastatic breast cancer whose disease progressed after prior endocrine therapy.
J&J Offers to Buy Out Japanese Cosmetics Company: J&J (JNJ - Free Report) offered to buy the remaining stake in Japanese cosmetics and skin care products company, Ci:z Holdings Co., Ltd for approximately 230 billion Japanese yen ($2.05 billion). J&J already owns 19.9% stake in Ci:z since July 2016 when J&J’s subsidiary, Cilag bought rights to distribute Ci:z’ products outside Japan and also acquired the stake. The acquisition will add Ci:z’ popular skincare brands like Dr.Ci:Labo, Labo Labo and Genomer to J&J’s product portfolio. J&J will be able to strengthen its presence in Japan's skincare market by accessing Ci:z’ large consumer base. (Read more: J&J Intends to Buy Residual Stake in Japanese Skincare Firm)
FDA Delays Approval Deadline of Bristol-Myers’ Cancer Drug Combo: The FDA has delayed its decision on Bristol-Myers’ regulatory application looking for the approval of a combination of its cancer drugs Opdivo plus Yervoy (low-dose) for the treatment of metastatic first-line non-small cell lung cancer. This is because Bristol Myers submitted additional information including overall survival data for a patient sub-group from the CheckMate 227 study to the FDA, which the latter categorized as a major amendment to the supplemental biologics license application (sBLA). As a result of the three-month delay, the FDA will now give its decision for the combination-drug treatment for lung cancer patients on May 20, 2019. (Read more: Bristol-Myers Declines, FDA Delays Review of Opdivo for NSCLC)
AstraZeneca to Buy Stake in Innate Pharma: AstraZeneca acquired full oncology rights to French drugmaker Innate Pharma’s anti-NKG2A antibody, monalizumab as well as option rights to Innate’s anti-CD39 monoclonal antibody, IPH5201 and four to-be-agreed preclinical molecules from its pipeline. In exchange, AstraZeneca will out-license U.S. and EU commercial rights to its recently FDA approved rare disease medicine, Lumoxiti (moxetumomab pasudotox) for hairy cell leukemia (HCL). In addition to making total payments of $170 million, AstraZeneca will acquire a newly issued 9.8% equity stake in Innate Pharma while the latter will make an upfront payment of $50 million to AstraZeneca for Lumoxiti.
AbbVie’s JAK1 inhibitor Meets Endpoints in Ulcerative Colitis Study: AbbVie (ABBV - Free Report) announced that a phase IIb/III dose-ranging study (U-ACHIEVE) evaluating its investigational JAK1 inhibitor, upadacitinib for moderately-to-severely active ulcerative colitis, met the primary endpoint of clinical remission and all ranked secondary endpoints including endoscopic improvement, clinical remission and clinical response. Based on data from this mid-stage study, phase III studies in ulcerative colitis have been initiated.
AbbVie also announced new patient-reported outcomes data from a late-stage rheumatoid arthritis study on upadacitinib. The data showed that treatment with upadacitinib monotherapy for 14 weeks led to significant improvement in physical function, pain and health-related quality of life in such patients compared to those receiving methotrexate.
Upadacitinib is one of the key candidates in AbbVie’s immunology pipeline and is in being evaluated in late-stage studies for Crohn’s disease, psoriatic arthritis and atopic dermatitis while a new drug application seeking approval for rheumatoid arthritis is expected to be filed soon.
AbbVie also announced that it is taking full commercial and development responsibility of all clinical/pre-clinical programs in cystic fibrosis products, which were originally discovered and developed jointly by AbbVie and Galapagos. AbbVie will now continue the development of the triple combination therapy for CF.
Pfizer/Lilly’s Pain Drug Shows Promise in Late-Stage Study: Pfizer and Lilly announced detailed data from a phase III study evaluating their pipeline candidate, tanezumab (subcutaneous) for the treatment of osteoarthritis (OA) pain of the knee or hip.
Top-line data from the study was announced in July when the company said that treatment with tanezumab led to statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA – the three primary endpoints – compared to placebo at 16 weeks. In the latest data presentation, the companies informed that over half of the patients treated with tanezumab reported a 50% or greater reduction in osteoarthritis pain of the knee or hip.
A potential approval to the candidate will provide a safer pain medication for patients in the United States where opioid abuse is widespread. Moreover, the currently approved drugs are underserving patients who continue to suffer from pain. Tanezumab is also being evaluated for chronic low back pain (CLBP) and cancer pain (due to bone metastases).
Meanwhile, Pfizer announced the creation of a new biotech called Cerevel Therapeutics in partnership with private equity firm Bain Capital, LP, which will focus on developing drugs to treat central nervous system (CNS) disorders, including Parkinson’s and Alzheimer’s disease. Pfizer will have a 25% stake in Cerevel. (Read more: Pfizer Succeeds in Pain Study, Forms JV to Make CNS Drugs)
Roche Gets FDA Nod for New Flu Medicine: Roche announced that the FDA approved Xofluza (baloxavir marboxil), its single-dose oral medicine with a novel mechanism of action to treat influenza or flu. The approval was based on data from the phase III CAPSTONE-1 study, which showed that a single-dose of Xofluza significantly reduced the duration of flu symptoms compared to placebo.
The NYSE ARCA Pharmaceutical Index declined 2.8% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
All stocks have recorded a decline this week. Bristol-Myers declined the most (12.8%) in the last five trading sessions.
In the past six months, Lilly (LLY) has been the biggest gainer (30.4%) while Bristol-Myers declined the most (5.8%).
(See the last pharma stock roundup here: ABBV, NVS' Humira Biosimilar Agreement, BMY's New Cancer Deal)
What's Next in the Pharma World?
Watch out for third-quarter earnings of several large drugmakers, including Pfizer and Allergan, and pipeline and regulatory updates next week.
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