“Oral therapies offer new opportunities for early intervention in diseases such as ulcerative colitis and could provide potential for combination therapies for patients with more severe conditions,” said Daniel Skovronsky, M.D., Ph.D., Chief Scientific Officer of Lilly and President of Lilly Research Laboratories and Lilly Immunology. “We look forward to welcoming the Morphic team to Lilly. This strategic acquisition strengthens our commitment to developing innovative therapies in gastroenterology, where Lilly has heavily invested in delivering first-in-class molecules to benefit patients.”
IDEAYA’s IDE397 Shows Positive Interim Results in Phase II Trial for MTAP-Deletion Urothelial and Lung Cancer
IDEAYA Biosciences, Inc. announced positive clinical data from the Phase II monotherapy expansion dose of IDE397 in patients with methylthioadenosine phosphorylase (MTAP)-deleted urothelial and non-small cell lung cancer (NSCLC). IDE397, a potent and selective methionine adenosyltransferase 2 alpha (MAT2A) inhibitor, is being evaluated as a potential first-in-class treatment for MTAP-deletion solid tumors in Phase II clinical trials.
Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer at IDEAYA Biosciences, remarked, “We are highly encouraged by the preliminary clinical efficacy and favorable safety profile observed with IDE397 at the 30mg once-a-day expansion dose, including multiple partial responses and one complete response by RECIST 1.1 in MTAP-deletion urothelial and lung cancer patients. In addition, at this expansion dose we observed a favorable adverse event profile with no drug-related serious adverse events and mid-single digit percent grade 3 or higher drug-related adverse events, which we believe has the potential to enable longer duration dosing as well as combinations.”
There are currently no FDA-approved therapies for MTAP-deletion solid tumors, highlighting a significant medical need. IDE397’s Phase II program focuses on urothelial cancer and NSCLC, with MTAP-deletion prevalence exceeding 15% and 25%, respectively, based on TCGA data. This corresponds to an estimated annual incidence of about 48,000 patients in the US. IDEAYA Biosciences is also exploring potential expansions into pancreatic, gastric, esophageal, and head and neck cancers, which also exhibit promising prevalence rates.
XPOVIO (selinexor) Gains Approval in China for Treating DLBCL, Offering Patients a Novel Therapeutic Choice
Antengene Corporation Limited announced that the China National Medical Products Administration approved XPOVIO (selinexor) as a standalone treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
The approval was based on data from the SEARCH study in China, involving 60 patients with DLBCL. Results showed that selinexor, administered orally, achieved a significant overall response rate as assessed by central radiological review, meeting the primary endpoint. This novel therapy offers efficacy and convenience, potentially reducing hospitalization and financial burdens for patients by enabling treatment at home.
Prof. Jun Zhu, principal investigator at Peking University affiliated Beijing Cancer Hospital, emphasized the critical need for effective therapies for R/R DLBCL in China, where NHL incidence continues to rise. Selinexor’s novel mechanism as a nuclear export protein inhibitor presents a promising new treatment option.
Globally, XPOVIO is the first orally available, selective XPO1 inhibitor, approved in over 40 countries and regions. It has secured health insurance coverage in China, Australia, Singapore, and South Korea, with pending approvals expected across ASEAN markets by the second half of 2024.
Antengene’s achievement with XPOVIO underscores its commitment to addressing unmet medical needs in oncology, particularly in challenging conditions like R/R DLBCL.
Roche to Relaunch Susvimo in the US for Patients with Neovascular Age-Related Macular Degeneration
Roche announced the relaunch of Susvimo for intravitreal use via ocular implant for wet AMD treatment in the US. This follows the conclusion of a voluntary recall, with the FDA approving a post-approval supplement to the Biologics License Application for Susvimo. The updates involve components of the ocular implant and refill needle. Roche aims to reintroduce Susvimo to retina specialists and their nAMD patients across the US in the coming weeks.
“We are excited to reintroduce Susvimo, a unique treatment option that has demonstrated efficacy in preserving vision with just two refills per year for patients with neovascular age-related macular degeneration in Phase III studies,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche. “The reintroduction of Susvimo underscores our steadfast commitment to advancing innovative therapies in retinal care and sets the stage for future advancements.”
Susvimo delivers a personalized formulation of ranibizumab continuously through the Port Delivery Platform, offering a significant advantage over other approved treatments that often require multiple eye injections annually.
The Susvimo implant is surgically placed into the eye in a one-time, outpatient procedure and refilled every six months using a specially designed needle that delivers a customized formulation of ranibizumab directly into the device. Approved by the FDA in 2021, Susvimo was voluntarily recalled by Roche the following year after some implants failed to meet the company’s performance standards. Roche has since updated the implant and refill needle, with testing confirming they now meet these standards. Additionally, manufacturing process improvements were implemented.
Roche remains committed to making this innovative drug delivery system available globally. This is one of several options Roche is developing to address the needs of people living with nAMD and other common eye conditions, including diabetic macular edema.
Dupixent Gains EU Approval as the First Targeted Therapy For COPD Patients
The European Commission approved Sanofi/Regeneron’s Dupixent for the treatment of chronic obstructive pulmonary disease (COPD) in patients with elevated blood eosinophils. Specifically, the approval includes patients currently using a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or a combination of a LABA and a LAMA if ICS is unsuitable. The EMA is the first regulatory authority worldwide to approve Dupixent for COPD patients. Additional submissions are under review by other regulatory authorities globally, including in the US, China, and Japan.
Tonya Winders, President & CEO of Global Allergy & Airways Patient Platform stated: “As a progressive and devastating disease, COPD causes breathlessness that restricts daily activities such as climbing stairs or walking to the mailbox. Many patients feel marginalized and isolated due to the physical and mental toll of the disease. After more than a decade of limited treatment advancements for those living with uncontrolled COPD, we are now in a new era of disease management for patients and caregivers. We welcome the addition of innovative new treatments like Dupixent to help manage this progressive and irreversible disease.”
The approval is based on results from the landmark phase III BOREAS and NOTUS studies, which were separately published in The New England Journal of Medicine. These studies evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD with evidence of type II inflammation (i.e., blood eosinophils ≥300 cells per μL). All patients were on background maximal standard-of-care inhaled therapy, with nearly all on triple therapy.
Dupixent is currently approved in multiple countries, including the US and EU, for the treatment of five type II inflammatory diseases: severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, and prurigo nodularis.
