The Tropion-Lung01 Phase III Trial Reveals that Datopotamab Deruxtecan Significantly Enhanced Overall Survival in Advanced Nonsquamous NSCLC Patients Compared to Chemotherapy

The high-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which had previously met the dual primary endpoint of progression-free survival (PFS), showed that datopotamab deruxtecan (Dato-DXd) was numerically favored over docetaxel in the overall population of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had received at least one prior line of therapy. However, the survival results did not achieve statistical significance in the overall trial population. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan demonstrated a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy.

The final analysis of overall survival (OS) is based on the positive progression-free survival (PFS) results presented at the 2023 European Society for Medical Oncology Congress. These results demonstrated that datopotamab deruxtecan significantly improved PFS in the overall trial population and provided a clinically meaningful PFS benefit for patients with nonsquamous NSCLC. In the TROPION-Lung01 study, patient enrollment by tumor histology was balanced across treatment arms and reflected real-world incidence, with approximately 75% of patients having nonsquamous NSCLC.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, stated: “Datopotamab deruxtecan stands out as the only investigational treatment to demonstrate a significant survival benefit for patients with previously treated nonsquamous non-small cell lung cancer compared to docetaxel, a standard that has remained unbeaten in the post-targeted treatment and post-immunotherapy context. These findings highlight the potential of datopotamab deruxtecan to supplant traditional chemotherapy in this advanced treatment setting and bolster our confidence in the ongoing trials assessing this therapy for first-line lung cancer.”

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody-drug conjugate developed by Daiichi Sankyo and co-developed by AstraZeneca and Daiichi Sankyo. Information regarding its efficacy will be shared at an upcoming medical conference, bolstering its regulatory submissions worldwide, notably in the US and EU, for treating adult patients with locally advanced or metastatic nonsquamous NSCLC who have previously undergone systemic therapy.

Biogen’s LEQEMBI Gains Approval in South Korea for Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. declared that South Korea’s Ministry of Food and Drug Safety (MFDS) has given the green light to “LEQEMBI®(lecanemab), a humanized monoclonal antibody targeting aggregated amyloid-beta (Aβ), for treating mild cognitive impairment or mild Alzheimer’s disease in adults.

LEQEMBI exhibits specific affinity towards soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are significant constituents of Aβ plaques observed in Alzheimer’s disease. Consequently, it diminishes the presence of both Aβ protofibrils and Aβ plaques within the brain. Notably, LEQEMBI stands as the pioneer treatment authorized to mitigate disease advancement and alleviate cognitive and functional deterioration via this pathway. South Korea joins the ranks as the fourth nation to endorse its usage, after approvals secured in the U.S., Japan, and China.

In 2021, South Korea had around 900,000 individuals affected by dementia, with approximately one out of every ten people over 65 experiencing dementia and one out of every five experiencing mild cognitive impairment (MCI). The average yearly expenses for nursing care and medical treatment per dementia patient were estimated at 21.1 million KRW, while those with severe dementia incurred costs of around 33.1 million KRW.

Eisai takes the helm in overseeing the global development and regulatory processes for LEQEMBI, with both Eisai and Biogen collaborating on its commercialization. Eisai holds the ultimate decision-making power. In South Korea, distribution and information provision for the product will be handled by Eisai Korea Inc. Eisai is dedicated to collaborating with healthcare professionals and other stakeholders to advance early diagnosis and treatment of Alzheimer’s disease.

AltruBio Raises $225M in Oversubscribed Series B to Propel Immune Checkpoint Enhancer Program

AltruBio Inc. revealed that its Series B financing round, which was in high demand, has secured funding totaling $225 million. The company intends to allocate these funds towards furthering the clinical progress of its innovative immune checkpoint enhancer (ICE) PSGL-1 agonist antibody, ALTB-268. Specifically, the financing will support the advancement of ongoing and forthcoming Phase II clinical trials focusing on ulcerative colitis, among other immunological disorders where the effectiveness of the mechanism has been confirmed through clinical validation.

The financing was led by BVF Partners LP with participation from new investors RA Capital Management, Cormorant Asset Management, Soleus Capital, and Delos Capital, as well as existing investors aMoon Fund and Blackstone Multi-Asset Investing, with other new and existing investors joining the syndicate.

Dr. Judy Chou, President and CEO of AltruBio, expressed gratitude for the esteemed new investors joining their ranks, highlighting how their support aligns with the existing investor base’s caliber. She emphasized the validation this collective backing provides for their program and mission of advancing durable biologic therapies for autoimmune disease patients. With this substantial investment, they move closer to advancing ALTB-268, a pioneering immune checkpoint enhancer, through Phase 2a biomarker study and initiating Phase 2b, with the potential to broaden its application beyond ulcerative colitis. Dr. Chou noted that their capable team and this significant funding position them to expedite efforts and deliver innovative treatments to those in need.

The pioneering ICE agonist antibody, ALTB-268, developed by the Company, is undergoing Phase IIa exploratory biomarker research in individuals with biologic refractory UC. The primary objective is to assess clinical remission based on a modified Mayo score, with results expected in the first half of 2025. Subsequently, the Company intends to launch a global Phase IIb trial, randomized and placebo-controlled, targeting clinical remission in patients with moderately to severely active UC, including those who have undergone advanced therapies and those who are treatment-naive. The outcome of this trial is projected to be available in the second half of 2026.

GSK’s Depemokimab Shows Promising Results in Phase III Severe Asthma Studies

GSK plc reported positive top-line results from the phase III clinical trials SWIFT-1 and SWIFT-2, which evaluated the effectiveness and safety of depemokimab compared to a placebo in adults and adolescents with severe asthma characterized by type 2 inflammation and elevated blood eosinophil levels. Both SWIFT-1 and SWIFT-2 achieved their primary goals, showing a reduction in the annual rate of clinically significant exacerbations (asthma attacks) over 52 weeks. In both trials, the frequency and severity of treatment-emergent adverse events were similar between the depemokimab and placebo groups. Further analysis of the data is currently underway.

Depemokimab is the pioneering ultra-long-acting biologic undergoing phase III trials, exhibiting high binding affinity and potency for interleukin-5 (IL-5), which allows for six-month dosing intervals in severe asthma patients. IL-5 is a crucial cytokine involved in type 2 inflammation, often marked by elevated blood eosinophil levels. This type of inflammation is the primary cause of over 80% of severe asthma cases and can result in unpredictable flare-ups.

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, stated: “These findings contribute to the existing evidence that targeting IL-5 inhibition is crucial in decreasing type 2 inflammation, which leads to severe asthma flare-ups. Depemokimab might provide sustained pathway inhibition, requiring only two injections annually. This is significant as studies indicate that 73% of physicians believe longer dosing intervals would benefit patients who frequently manage multiple treatments.”

Expertise in respiratory diseases and IL-5 science has guided the ongoing evidence-generation program assessing the effects of six-month dosing of sustained IL-5 inhibition in patients with severe asthma who have achieved clinical remission. The comprehensive results of the SWIFT-1 and SWIFT-2 studies will be presented at an upcoming scientific congress and will aid in regulatory submissions to health authorities globally. Depemokimab is not yet approved in any country.

Roche’s Inavolisib Receives FDA Breakthrough Therapy Designation for Advanced HR+ HER2- Breast Cancer with PIK3CA Mutation

Roche has revealed that the FDA has awarded Breakthrough Therapy Designation to inavolisib, an experimental oral treatment when used alongside palbociclib (Ibrance®) and fulvestrant. This combination is intended for adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, who have experienced a recurrence during or within 12 months after finishing adjuvant endocrine therapy.

“We are delighted that the FDA has awarded Breakthrough Therapy Designation to inavolisib, acknowledging the significant clinical benefits seen with this treatment,” stated Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche. “This promising inavolisib-based therapy has the potential to revolutionize the PI3K inhibitor class and may become the standard first-line treatment for this patient group.”

The FDA’s decision is based on the positive results from the Phase III INAVO120 trial, which demonstrated that the inavolisib-based treatment regimen reduced the risk of disease progression or death (progression-free survival) by 57% compared to the combination of palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001). Although the overall survival (OS) data are still immature, there is a clear positive trend observed (stratified HR=0.64, 95% CI: 0.43-0.97, p=0.0338 with a boundary of 0.0098). Follow-up for overall survival will continue until the next analysis. These findings highlight the potential of the inavolisib-based regimen to benefit patients with PIK3CA-mutated locally advanced or metastatic breast cancer.

Inavolisib is presently undergoing evaluation in three company-sponsored Phase III clinical trials (INAVO120, INAVO121, INAVO122) for PIK3CA-mutated locally advanced or metastatic breast cancer, in various combination therapies. We are also exploring opportunities to expand our clinical development program to address unmet patient needs in different tumor types across oncology.