Davy James

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.

Ebglyss (lebrikizumab-lbkz) shows significant efficacy in reducing skin symptoms and itch in moderate-to-severe atopic dermatitis patients, including those who previously discontinued Dupixent.

Respiratory syncytial virus (RSV) vaccine Arexvy shows strong immune responses in adults aged 18-49 with an elevated risk for RSV lower respiratory tract disease, including immunocompromised adults, suggesting the potential to expand the vaccine's use beyond its current approval in older age groups.

Data from the Phase III SOUL trial demonstrated that oral semaglutide (Rybelsus) significantly reduced major adverse cardiovascular events in patients with type 2 diabetes and cardiovascular or kidney disease, providing evidence for its cardiovascular benefits and supporting a potential label expansion.

Phase IV ELEVATUM trial results show that one year of treatment with Vabysmo significantly improved vision in underrepresented racial and ethnic groups with diabetic macular edema, supporting the drug's efficacy and safety across diverse populations.

The combination of islatravir (Merck) and lenacapavir (Gilead) demonstrated high efficacy in maintaining a 94.2% viral suppression rate in virologically suppressed adults with HIV after 48 weeks of treatment in a Phase II trial.

Merck's investigational monoclonal antibody, clesrovimab, shows significant efficacy in reducing respiratory syncytial virus-related infections and hospitalizations in infants, with a favorable safety profile.

The combination of Opdivo (nivolumab) plus chemotherapy significantly improved progression-free survival compared to Adcetris (brentuximab vedotin) plus chemotherapy in patients with advanced stage Hodgkin lymphoma, based on findings from the Phase III S1826 trial.

Real-world data presented at IDWeek 2024 show Apretude (cabotegravir long-acting) is more than 99% effective in preventing HIV infection, with high adherence rates, reduced stigma and anxiety, and broad acceptability.

Preliminary data from the Phase III IMforte trial show the combination of Zepzelca (lurbinectedin) plus Tecentriq (atezolizumab) significantly improved overall survival and progression-free survival in patients with extensive-stage small cell lung cancer.

Data from the RAINBOWFISH trial shows early treatment with Evrysdi (risdiplam) in pre-symptomatic infants with spinal muscular atrophy (SMA) leads to significant motor milestone achievements, such as standing and walking, as well as cognitive development typical of non-SMA children, without the need for permanent ventilation.

Tremfya (guselkumab) demonstrated superior endoscopic remission rates in both Crohn disease and ulcerative colitis, including biologic-naïve and biologic-refractory patients, according to Phase III clinical trial data.

Talzenna (talazoparib) with Xtandi (enzalutamide) produced a statistically significant improvement in overall survival among patients with metastatic castration-resistant prostate cancer, regardless of mutation status, making it the first combination of a PARP inhibitor and ARPI to achieve these results.

KEYNOTE-689 trial shows Keytruda (pembrolizumab) produced significantly improved event-free survival and major pathological response in patients with resected, locally advanced head and neck squamous cell carcinoma, marking the first Phase III trial to show meaningful results with an anti-PD-1 therapy in both the neoadjuvant and adjuvant settings.

Twice-yearly lenacapavir, a long-acting HIV-1 capsid inhibitor, reduced HIV infections by 96% in the Phase III PURPOSE 2 trial while showing superior efficacy over daily Truvada.

Findings from the BATURA Phase IIIb trial demonstrated that Airsupra (albuterol/budesonide) significantly reduced the risk of severe asthma exacerbations in patients with intermittent or mild persistent asthma compared to albuterol alone.

In the Phase II PATH-HHT trial, pomalidomide significantly reduced the severity of epistaxis and improved quality of life in patients with hereditary hemorrhagic telangiectasia, offering a potential treatment for the bleeding disorder, which currently lacks FDA-approved therapies.

Ziresovir is a potent, selective, orally bioavailable RSV F protein inhibitor, that has been shown to reduce viral load and the Wang Respiratory Score with a favorable safety profile in hospitalized infant patients with respiratory syncytial virus infection.

Proof-of-concept Phase II ARTEMIS-UC trial shows efficacy of investigational humanized monoclonal antibody tulisokibart in treating inflammatory bowel disease compared with placebo.

Beqvez (fidanacogene elaparvovec), a one-time gene therapy, was approved by the FDA in April 2024 to treat adults with moderate to severe hemophilia B.