This week Merck MRK announced a definitive deal to buy private preclinical cancer biotech Tilos Therapeutics. In other news, Roche RHHBY won FDA approval for polatuzumab vedotin, to be marketed as Polivy, for diffuse large B-cell lymphoma (DLBCL) while Merck’s blockbuster PD-L1 inhibitor Keytruda won approval for first-line treatment of head and neck cancer.
Recap of the Week’s Most Important Stories
Merck to Buy Tilos Therapeutics, Gets FDA Nod for Keytruda for First-Line Head/Neck Cancer: Merck announced a definitive deal to buy private biotech Tilos Therapeutics for a total potential purchase price of up to $773 million. The deal includes an undisclosed upfront payment and contingent milestone payments. The acquisition will add Tilos’ portfolio of pre-clinical antibodies, targeting a protein called TGFβ, being developed for various forms of cancer, fibrosis and autoimmune disease.
The FDA granted approval to Keytruda for first-line treatment of metastatic or unresectable, recurrent head and neck squamous cell cancer (HNSCC) as monotherapy in patients whose tumors express PD-L1 or in combination with chemotherapy regardless of PD-L1 expression. The sBLA was based on data from the phase III KEYNOTE-048 study, wherein Keytruda, as a monotherapy and in combination with chemotherapy, demonstrated significant improvement in overall survival (OS) compared to the standard of care in the given patient population. Keytruda was approved in 2016, on an accelerated basis, for recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. With the approval to include data from the KEYNOTE-048 study on Keytruda’s label, the accelerated approval gets converted to a regular approval.
FDA Grants Approval to Roche’s Polivy for DLBCL: The FDA granted accelerated approval to Roche’s biologics license application (BLA) looking for approval of its anti-CD79b antibody drug conjugate (ADC), polatuzumab vedotin as a combination therapy for the treatment of relapsed or refractory (R/R) DLBCL. Polatuzumab vedotin will be marketed by the trade name of Polivy and has been approved for use in combination with bendamustine plus Rituxan (BR). The decision came earlier than expected in August. Polatuzumab vedotin is being evaluated for the treatment of several types of non-Hodgkin lymphoma (NHL).
The FDA also accepted and granted priority review to Roche’s supplemental biologics license application (sBLA) looking for label expansion of Rituxan, in combination with glucocorticoids, to treat children with two rare blood vessel disorders, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
Meanwhile, Rituxan met the primary and secondary endpoints in the phase III PEMPHIX study comparing it to mycophenolate mofetil (MMF), an immunosuppressive drug, in adults with pemphigus vulgaris (PV). In the study, Rituxan was demonstrated to be superior to MMF in achieving sustained complete remission. Rituxan is already approved to treat PV and the latest data provides additional clinical evidence on the effectiveness of Rituxan for the rare and serious disease.
Update from ADA: Key players in the diabetes market, Lilly LLY, Sanofi SNY and Novo Nordisk NVO made data presentations from key diabetes studies at the scientific session of the American Diabetes Association (ADA).
Lilly presented additional data from two phase III studies — PRONTO-T1D and PRONTO-T2D — evaluatingits investigational ultra-rapid-acting lispro (URLi) for the treatment of type I and type II diabetes. Data from the study showed URLi provided similar A1C (an overall measure of glucose control) reductions compared to Humalog and also led to superior reduction in blood glucose spike post meals.
At ADA, Lilly also presented data from an outcomes study (REWIND) on Trulicity, which showed that the GLP-1 receptor agonist led to a 12% reductionin cardiovascular (CV) events like CV death, non-fatal myocardial infarction (heart attack) or non-fatal stroke in a broad range of type II diabetes patients. However, the 12% reduction fell short of investor expectations. In addition, Lilly also presented data from a study on tirzepatide, its dual GIP and GLP-1 receptor agonist and detailed results from CAROLINA outcomes study on DPP-4 inhibitorTradjenta.
Novo Nordisk presented data from the PIONEER 6 cardiovascular outcomes study evaluating oral semaglutide versus placebo in patients with type II diabetes and established cardiovascular disease. The data demonstrated that oral semaglutide does not increase the risk of major adverse cardiovascular events. Novo Nordisk also presented 26 and 52-week data from two phase IIIa studies evaluating oral semaglutide versus Lilly’s Jardiance (PIONEER 2 study) and its own GLP-1 receptor agonist Victoza (PIONEER 4 study) in type II diabetes. The data demonstrated that at 26 weeks, treatment with oral semaglutide led to superior reductions in blood sugar versus Jardiance and non-inferior blood sugar reductions versus Victoza.
Sanofi presented data from a phase III study evaluating Soliqua in type II diabetes patients whose disease was inadequately controlled by GLP-1 receptor agonist. The data showed that Soliqua significantly lowered blood sugar levels compared to GLP-1 receptor agonist treatments in such patients.
AstraZeneca’s AZN Farxiga showed reduced progression of kidney disease or renal death in patients with type II diabetes per data from a pre-specified analysis of the phase III DECLARE-TIMI 58 outcomes study on the SGLT2 inhibitor. Farxiga showed a 47% reduction in the composite of kidney function decline, end-stage renal disease or renal death compared to placebo in the study. The DECLARE-TIMI 58 is evaluating Farxiga to reduce the risk of renal or cardiovascular death or to slow the progression of kidney disease in type II diabetes patients.
J&J JNJ presented new data from the CREDENCE outcomes study on a SGLT2 inhibitor, Invokana.
The NYSE ARCA Pharmaceutical Index rose 1.6% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
Last week, while J&J and Glaxo recorded the highest gain (3%), Lilly declined the most (4.2%).
In the past six months, Merck has been the biggest gainer (10.2%) while Bristol-Myers declined the most (7.1%).
(See the last pharma stock roundup here: ASCO Update, FDA Nod for LLY’s Emgality for Cluster Headache)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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