Davy James

Prasinezumab did not achieve statistical significance for its primary endpoint in the Phase IIb PADOVA trial for early-stage Parkinson's disease, but showed potential clinical efficacy with positive trends in motor progression and secondary outcomes.

Depemokimab, an ultra-long-acting anti–IL-5 biologic therapy, significantly reduced annual asthma exacerbations in patients with severe eosinophilic asthma while maintaining a favorable safety profile, offering the potential for improved patient quality of life with reduced dosing frequency.

Results from the EMBER-3 trial show imlunestrant, both as monotherapy and in combination with Verzenio (abemaciclib), significantly improved progression-free survival in ESR1-mutated ER-positive, HER2-negative advanced breast cancer.

Data from the OlympiA Phase III trial show Lynparza (olaparib) significantly improved the risk of death, invasive disease-free survival, and distant disease-free survival over six years in patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

Results from the DREAMM-7 Phase III trial demonstrated that Blenrep (belantamab mafodotin) combined with bortezomib and dexamethasone significantly improved overall survival, progression-free survival, and treatment response in relapsed or refractory multiple myeloma compared to a daratumumab-based regimen.

Phase III CARTITUDE-4 trial shows Carvykti significantly improves minimal residual disease negativity rates, progression-free survival, and overall survival compared to standard therapies for patients with relapsed or refractory multiple myeloma, especially when used earlier in treatment.

The Phase III AALL1731 trial demonstrated that adding Blincyto (blinatumomab) to chemotherapy significantly improved three-year disease-free survival in pediatric patients with standard-risk B-cell acute lymphoblastic leukemia.

Merck and Ridgeback Biotherapeutics have launched the Phase III MOVe-NOW trial to evaluate a new, streamlined formulation of Lagevrio (molnupiravir) for treating non-hospitalized COVID-19 patients at high risk of severe disease progression who are unable to use other antiviral therapies.

Phase II Piranga trial found that the combination of xalnesiran and an immunomodulator effectively reduced hepatitis B surface antigen (HBsAg) levels, but highlighted challenges in response durability and efficacy in patients with high HBsAg levels.

Publicly funded non-inferiority trials have grown in popularity with high levels of non-inferiority margin reporting; however, a recent analysis notes a need for improved design and reporting practices to ensure clinical relevance and reliability.

CAR T-cell therapy obecabtagene autoleucel produced high response rates, durable outcomes, and low toxicity in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, especially benefiting those with low-to-intermediate bone marrow burden.

Phase III CheckMate 8HW trial results demonstrated that the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improves progression-free survival and has a better safety profile compared to chemotherapy in the first-line treatment of MSI-H or dMMR metastatic colorectal cancer.

Results from a followup evaluation of COLOFOL trial show no significant improvement in 10-year overall or colorectal cancer–specific mortality rates between high-frequency and low-frequency postoperative follow-up regimens for patients with stage II or III colorectal cancer.

The Phase II KRAKEN trial demonstrated that muvalaplin, Eli Lilly's first-in-class oral small molecule inhibitor, significantly reduces lipoprotein(a) levels with minimal adverse effects, offering a promising new approach to addressing a major cardiovascular risk factor.

Zerlasiran, a novel siRNA therapy, demonstrated over 80% sustained reductions in lipoprotein(a) levels with infrequent dosing in the Phase II ALPACAR-360 trial, highlighting its potential as a safe and effective treatment for patients at high risk of cardiovascular disease.

The Phase III CLEAR SYNERGY trial found that long-term colchicine treatment after acute myocardial infarction does not reduce major cardiovascular events compared to placebo, highlighting mixed results from prior studies on its efficacy in cardiovascular disease.

The Phase III SUMMIT trial showed that tirzepatide significantly reduces the risk of worsening heart failure events or death from cardiovascular causes, enhances physical function, and leads to weight loss and reduced inflammation in patients with heart failure with preserved ejection fraction.

Multiple Phase III trials and open label extensions show Bimzelx (bimekizumab-bkzx) offers an effective approach in targeting key inflammatory pathways involved in psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.

Phase III DREAMM-7 trial data show that the combination of Blenrep (belantamab mafodotin) with bortezomib and dexamethasone (BorDex) significantly improved overall survival in patients with relapsed or refractory multiple myeloma compared to standard treatment with Darzalex (daratumumab) and BorDex.

Full Phase III PURPOSE 2 trial results suggest that twice-yearly lenacapavir could revolutionize HIV prevention by offering a convenient and effective long-acting option for individuals at risk of infection.

Phase III COMBI-AD trial final analysis shows that 12 months of adjuvant therapy with Tafinlar (dabrafenib) and Mekinist (trametinib) in patients with resected stage III melanoma significantly improved relapse-free survival and distant metastasis-free survival compared to placebo.

Phase III WAYPOINT trial found that Tezspire (tezepelumab-ekko) effectively reduced nasal polyp size and congestion in patients with chronic rhinosinusitis with nasal polyps, offering a promising new treatment option with a consistent safety profile.

An interim analysis of the Phase III ALIGN trial found that 36 weeks of treatment with atrasentan significantly reduced proteinuria in high-risk IgA nephropathy patients with a favorable safety profile, supporting its potential role in managing the disease.

The STEP 9 trial found that once-weekly semaglutide significantly reduced knee osteoarthritis pain and body weight in patients with obesity, improved physical function, and potentially reduced the need for NSAIDs and opioids.

A post hoc analysis of the SELECT trial shows semaglutide 2.4 mg significantly reduced hospital admissions and hospital stay lengths in adults with obesity or overweight and cardiovascular disease but without diabetes.

Cobenfy (xanomeline and trospium chloride) demonstrated sustained long-term efficacy, safety, and tolerability over 52 weeks in Phase III trials for adult schizophrenia patients, showing significant symptom improvement and quality of life benefits with minimal adverse effects.

INAVO120 Phase III trial shows Itovebi (inavolisib) plus Ibrance (palbociclib) and Faslodex (fulvestrant) is a promising first-line treatment option that effectively targets disease pathways with durable clinical benefits for PIK3CA-mutated, endocrine-resistant, HR-positive, HER2-negative metastatic breast cancer.

EMPA-KIDNEY trial shows that two years of treatment with Jardiance (empagliflozin) significantly lowered the risk of chronic kidney disease progression and cardiovascular death, with lasting cardiorenal benefits up to one year after treatment ended.

Phase III GRAVITI trial results show Tremfya (guselkumab) administered subcutaneously provides significant clinical remission and endoscopic response at 48 weeks for patients with moderate to severe Crohn's disease, offering a promising new treatment option with both subcutaneous and intravenous induction routes.

Omvoh (mirikizumab) becomes the first IL23p19 antagonist to show multi-year, long-term sustained efficacy in both ulcerative colitis and Crohn disease, with Phase III trials showing high rates of clinical and endoscopic remission with a consistent safety profile.