This week, Lilly LLY began phase I study on a potential antibody therapy to treat COVID-19. AstraZeneca AZN announced two new supply deals, which will require it to raise its manufacturing capacity for its coronavirus vaccine doses to 2 million, if it is successful. The FDA granted approvals for Lilly’s Cyramza & Taltz, AstraZeneca’s Brilinta, Roche’s RHHBY Tecentriq+Avastin and AbbVie’s ABBV Elagolix for new indications.
Recap of the Week’s Most Important Stories:
Lilly Begins Clinical Study on Coronavirus Antibody Candidate: Lilly said that the first patients have been dosed in a phase I study on LY-CoV555, its lead antibody therapy candidate in collaboration with private biotech, AbCellera. Lilly signed the deal with AbCellera in March to create antibody therapies to treat and prevent COVID-19. LY-CoV555 is the first candidate to emerge from the collaboration. The phase I study on LY-CoV555 will evaluate its safety and tolerability in patients hospitalized with COVID-19. Results from the study are expected in June. Lilly is also beginning large-scale manufacturing of this potential therapy simultaneously with its R&D efforts.
The FDA approved Lilly’s Cyramza as a combination regimen for metastatic EGFR-mutated non-small cell lung cancer. With the latest approval, Cyramza is now approved for six indications to treat certain types of lung, liver, stomach and colorectal cancers. FDA approval for label expansion of Cyramza was based on data from the phase III RELAY study.
The FDA also approved Taltz injection for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. With the approval, Taltz is now approved to treat patients across the full axSpA spectrum, including ankylosing spondylitis (AS), also known as radiographic axSpA, and nr-axSpA.
AstraZeneca Signs Two New Supply Deals for COVID-19 Vaccines: AstraZeneca announced agreements worth $750 million with Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi the Vaccine Alliance to produce and supply 300 million doses of the coronavirus vaccine which it is developing with Oxford University. The two organizations are backed by Bill and Melinda Gates. It expects to begin delivery of the vaccine before the end of 2020. AstraZeneca has an agreement with Oxford University for the global development and distribution of the University’s potential recombinant adenovirus vaccine, also known as AZD1222, to prevent COVID-19. AstraZeneca also reached a deal with the Serum Institute of India (SII) to supply one billion doses of the vaccine to India and other low and middle-income countries. AstraZeneca has committed to provide 400 million doses to SII before the end of the year.
AZD1222 is currently being evaluated in a phase II/III study, with around 10,000 volunteers, which Oxford University initiated recently. Last month, AstraZeneca received more than $1billion in funding from BARDA to help produce the vaccine. AstraZeneca recently also secured agreements to supply at least 400 million doses to the United States and United Kingdom.
The FDA granted approval to AstraZeneca’s blood thinner medicine, Brilinta for reducing the risk of a first heart attack or stroke in high-risk patients with coronary artery disease, which is the most common type of heart disease. The approval was based on data from the phase III THEMIS study. Similar label expansion applications are under review in EU, Japan and China.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for AstraZeneca/Merck’s Lynparza as a first-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer. The recommendation was based on data from the phase III POLO study. Lynparza is already approved in the United States for this patient population based on the Phase III POLO study.
AstraZeneca also collaborated with Massachusetts-based private biotech, Accent Therapeutics to discover, develop and commercialize transformative therapeutics targeting RNA-modifying proteins (RMPs) for the treatment of cancer.
FDA Approves AbbVie’s Elagolix for Uterine Fibroids Indication: The FDA approved AbbVie and Neurocrine Biosciences elagolix for reducing heavy menstrual bleeding (HMB) in premenopausal women with uterine fibroids. The oral medicine will be marketed by the trade name of Oriahnn. Elagolix is already marketed by the trade name of Orilissa for management of pain associated with endometriosis, a common gynecologic disorder. Orilissa was approved in 2018.
AbbVie filed regulatory applications to the FDA as well as EMA seeking approval of Rinvoq (upadacitinib) for a second indication—active psoriatic arthritis. Rinvoq was approved by the FDA in August and by EMA in December last year for treating for moderate-to-severe rheumatoid arthritis (RA)
AbbVie also entered into a strategic collaboration with small biotech, Jacobio Pharmaceuticals to develop and commercialize SHP2 inhibitors, which target a key node in cancer and immune cells.
FDA Approves Roche’s Tecentriq+Avastin for Liver Cancer: The FDA also approved Roche’s cancer immunotherapy regimen, Tecentriq plus Avastin for the treatment of unresectable or metastatic hepatocellular carcinoma, an aggressive form of liver cancer. The approval was based on data from the phase III IMbrave150 study which showed that the Tecentriq+Avastin combo improved overall survival and progression-free survival compared to the standard-of-care medicine, Nexavar (sorafenib).
IDMC Says Pfizer’s Early Breast Cancer Study on Ibrance May Fail: An independent Data Monitoring Committee (DMC) recommended that Pfizer’s PFE phase III study evaluating its blockbuster drug Ibrance in an early breast cancer indication may not show statistically significant improvement in its primary endpoint of invasive disease-free survival. Ibrance is presently marketed for HR+, HER2- advanced or metastatic breast cancer indications and is not approved for any early breast cancer indication.
Bristol-Myers Succeeds in Pivotal Ulcerative Colitis Study: Bristol-Myers’ BMY pivotal phase III study (True North), evaluating its newly-launched multiple sclerosis drug Zeposia (ozanimod) for moderate-to-severe ulcerative colitis met its co- primary endpoints. The study demonstrated highly statistically significant results for induction of clinical remission at week 10 and in maintenance at week 52, the study’s primary endpoints. The study also met key secondary endpoints. Zeposia was added to Bristol-Myers’ portfolio with the 2019 acquisition of Celgene. Zeposia was approved by the FDA for relapsing forms of multiple sclerosis (RMS) in March this year and launched in June.
FDA Delays Decision on Novartis’ Ofatumumab: The FDA extended its review of Novartis’ NVS supplemental biologics license application (sBLA), seeking approval of ofatumumab by three months. Novartis has developed ofatumumab, a fully human anti-CD20 monoclonal antibody (mAb) targeting B-cells, for treating RMS as a subcutaneous therapy that can be self-administered (by a once-monthly injection) at home. The candidate is also under review in EU.
EU Approval to Sanofi’s Sarclisa and J&J’s Darzalex Subcutaneous: The European Commission approved Sanofi’s Sarclisa (isatuximab) in combination with pomalidomide and dexamethason for the treatment of relapsed/refractory (third-line) multiple myeloma (RRMM). Sarclisa was approved in the United States in March.
The EC also approved J&J’s subcutaneous formulation of Darzalexfor all currently approved multiple myeloma indications for the intravenous formulation of Darzalex. The subcutaneous formulation of Darzalex was approved in the United States in May.
ASCO Update: Several companies presented data from cancer studies at virtual annual meeting of the American Society of Clinical Oncology (ASCO).
Merck presented data from two studies on Keytruda plus Lenvima, which showed that the combination treatment led to clinically meaningful tumor response rates in unresectable hepatocellular carcinoma and advanced renal cell carcinoma. In a study evaluating Keytruda monotherapy for first-line treatment of patients with MSI-H colorectal cancer, Keytruda significantly reduced risk of disease progression or death by 40% and more than doubled median progression-free survival versus chemotherapy.
Novartis’s data from the COMBI-AD study showed that treatment with Tafinlar + Mekinist following surgery leads to long-term and durable relapse-free survival (RFS) benefit in high-risk, stage III melanoma patients. The data showed that 52% of patients treated with adjuvant Tafinlar + Mekinist were alive and relapse-free at five years.
Roche’s data from a global phase III study demonstrated that its drug, Alecensa leads to clinically meaningful benefit in overall survival at five years compared with crizotinib in patients with ALK-positive NSCLC.
AstraZeneca presented detailed results from phase II studies, which showed that its partnered drug Enhertu led to clinically meaningful improvement in tumor responses/survival benefit in HER2-positive metastatic gastric cancer and ER2-mutant NSCLC and HER2-positive metastatic colorectal cancer. It also presented detailed data from two combination studies on Imfinzi.
Sanofi presented longer-term results from two pivotal studies on Libtayo in advanced cutaneous squamous cell carcinoma, which demonstrated both longer durability and higher complete response (CR) rates than previously reported.
The NYSE ARCA Pharmaceutical Index declined 0.29% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the nine major stocks performed in the last five trading sessions.
Last week, AbbVie rose the most (3.4%) while Pfizer declined the most (5.7%).
In the past six months, Lilly has risen the most (26%) while Merck declined the most (8.2%).
(See the last pharma stock roundup here: MRK, RHHBY Give Coronavirus Updates, SNY to Sell Stake in REGN)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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