Trodelvy-Keytruda Combination Shows Promising Results in First-Line Treatment for Triple-Negative Breast Cancer
• Gilead Sciences and Merck's phase 3 ASCENT-04/KEYNOTE-D19 trial demonstrated statistically significant improvement in progression-free survival with Trodelvy plus Keytruda compared to Keytruda with chemotherapy in metastatic TNBC patients.
• The novel combination of antibody-drug conjugate (Trodelvy) with immunotherapy (Keytruda) represents a potential paradigm shift in treatment approach for aggressive triple-negative breast cancer, potentially displacing conventional chemotherapy.
• Early data shows a positive trend toward improved overall survival, with detailed results to be presented at upcoming medical meetings and discussed with regulatory authorities.
Brain Hemorrhage Treatment Market Expected to Grow Significantly by 2032 as AI Solutions Gain FDA Approval
• The brain hemorrhage treatment market is projected to experience substantial growth through 2032, driven by an aging population and increasing prevalence of risk factors such as hypertension and traumatic brain injuries.
• Recent FDA approvals for AI-based diagnostic tools, including JLK-LVO and Heuron ICH, mark significant advancements in early detection and treatment of brain hemorrhages.
• Several pharmaceutical companies including Baxter, Pfizer, and Novartis are developing promising pipeline therapies such as tissue plasminogen activator, alteplase, and BAF312 to address the significant unmet needs in brain hemorrhage treatment.
RSV Treatment Landscape Expands with New Vaccines and Clinical Trials in 2024-2025
• Moderna's mRESVIA vaccine received MHRA approval in February 2025 for adults aged 60 and older, joining GSK's Arexvy and Pfizer's Abrysvo in the expanding RSV vaccine market.
• The FDA has mandated new safety warnings for RSV vaccines regarding Guillain-Barré Syndrome risk, highlighting ongoing safety monitoring efforts in early 2025.
• Multiple pharmaceutical companies including Sanofi, GSK, and Pfizer are conducting advanced clinical trials in 2024, focusing on various patient populations and novel therapeutic approaches.
Chinese Cancer Drug Outperforms Merck's Keytruda in Landmark Lung Cancer Trial
• A novel Chinese experimental cancer drug has demonstrated unprecedented efficacy in late-stage trials, nearly doubling progression-free survival in non-small-cell lung cancer patients compared to Keytruda.
• Merck's Keytruda, a leading cancer immunotherapy drug, has generated over $130 billion in sales since 2014, including $29.5 billion in the previous year.
• The breakthrough Chinese trial results of 11.1 months versus Keytruda's 5.8 months mark a significant advancement in cancer immunotherapy and challenge Western pharmaceutical dominance.
Major Pipeline Expansion in Schizophrenia Treatment: 55+ Companies Developing 60+ Novel Therapies
• DelveInsight's latest pipeline report reveals over 55 pharmaceutical companies actively developing 60+ innovative drug candidates for schizophrenia treatment, indicating significant industry investment in addressing this serious mental illness.
• Several promising candidates are advancing in clinical trials, including Lyndra's weekly oral risperidone (LYN-005), AbbVie's selective M4 receptor PAM emraclidine, and Kynexis's cognitive function-targeting KYN-5356.
• Multiple clinical trials are scheduled for early 2025, including LB-102 for acute schizophrenia, Click Therapeutics' digital therapeutics, and Cerevel's emraclidine safety study, demonstrating diverse therapeutic approaches.
NICE Recommends Keytruda for Second-Line Lung Cancer Treatment Following Price Reduction
NICE has approved Keytruda for second-line treatment of PD-L1 positive non-small-cell lung cancer after Merck Sharp & Dohme agreed to a price cut. This decision marks a significant advancement in immunotherapy for lung cancer, potentially extending patients' lives by more than three months compared to standard therapy. However, treatment is limited to two years due to uncertainties in long-term data.
Durvalumab Improves PFS in Unresectable NSCLC After Chemoradiotherapy
• The PACIFIC-5 study demonstrated that durvalumab consolidation therapy significantly improved progression-free survival (PFS) in patients with unresectable NSCLC.
• A 25% reduction in the risk of disease progression or death was observed with durvalumab compared to placebo (HR, 0.75; 95% CI, 0.58-0.99; P = .038).
• The median PFS was 14.0 months in the durvalumab arm versus 6.5 months in the placebo arm, showing a clinically meaningful benefit.
• The safety profile of durvalumab was consistent with previous studies, supporting its use as consolidation therapy after chemoradiotherapy.
Pancreatic Cancer: Advances in Treatment and Research Bring Hope in 2024
• The five-year relative survival rate for pancreatic cancer has risen to 13%, marking the third consecutive year of improvement, yet it remains the lowest among major solid tumors.
• Four new drug approvals for pancreatic cancer occurred in 2024, including one first-line treatment and three targeted agents for previously treated advanced disease.
• A Phase 3 clinical trial demonstrated an overall survival benefit using Tumor Treating Fields (TTFields) in combination with chemotherapy for unresectable, locally advanced pancreatic cancer.
• Precision medicine is advancing with the FDA approval of Bizengri for NRG1 fusion-positive pancreatic cancer and the ongoing RASolute 302 trial evaluating RMC-6236, a RAS inhibitor.
Lupin Receives Tentative FDA Approval for Generic Janumet
• Lupin has been granted tentative FDA approval for its generic version of Janumet (sitagliptin and metformin hydrochloride) tablets, used to manage type 2 diabetes.
• The generic drug will be available in 50 mg/500 mg and 50 mg/1000 mg strengths, mirroring the original Janumet formulation.
• Sitagliptin and metformin hydrochloride tablets are indicated to improve glycemic control in adult patients with type 2 diabetes mellitus when used alongside diet and exercise.
• Janumet tablets had an estimated annual sale of $1.145 billion in the U.S. as of September 2024, according to IQVIA data.
Follicular Lymphoma Pipeline Shows Promise with Over 55 Therapies in Development
• The follicular lymphoma treatment landscape is evolving, with over 55 therapies in development by more than 50 active pharmaceutical companies.
• Key players like Incyte, AstraZeneca, and Johnson & Johnson are evaluating novel drugs, including CAR-T therapies and targeted agents, to improve patient outcomes.
• Tafasitamab is expected to have a supplemental Biologics License Application filed in August 2024 for patients who have failed prior therapies.
• Emerging therapies in the pipeline include TQ-B3525, NKTR-255, and Zilovertamab vedotin, targeting various mechanisms to combat follicular lymphoma.
Niraparib Shows Promise in Extending Progression-Free Survival in Epithelial Ovarian Cancer
• Niraparib monotherapy extends real-world progression-free survival (rwPFS) and time to next treatment (rwTTNT) in patients with epithelial ovarian cancer (EOC).
• Patients with homologous recombination-deficient (HRd) tumors, particularly those with BRCA-mutated tumors, experienced longer rwPFS and rwTTNT.
• Niraparib demonstrates clinical benefit in stage III EOC patients with no visible residual disease (NVRD) after primary cytoreductive surgery (PCS).
• Niraparib stands out among PARP inhibitors for its broad frontline maintenance therapy approval in EOC, regardless of BRCA mutation or HRD status.
Acoramidis Gains Global Momentum: FDA Approval, EU Recommendation, and Promising Clinical Data
• Acoramidis (Attruby), developed by Stanford Medicine and BridgeBio, receives FDA approval for transthyretin amyloid cardiomyopathy (ATTR-CM) treatment, marking a significant milestone.
• The European Medicines Agency's CHMP recommends acoramidis for EU marketing authorization based on positive Phase 3 ATTRibute-CM trial results.
• Clinical trials demonstrate acoramidis' efficacy in reducing cardiovascular-related hospitalizations and improving survival rates for ATTR-CM patients.
• Bayer and BridgeBio collaborate to commercialize acoramidis, with Bayer holding EU rights and plans for a launch in Europe in early 2025.
Pembrolizumab Plus Radiation and Surgery Improves Outcomes in Stage III Soft-Tissue Sarcoma
• A phase II trial (SU2C-SARC032) found that adding pembrolizumab to preoperative radiation and surgery improved disease-free survival in stage III soft-tissue sarcoma patients.
• Two-year disease-free survival was 67% with pembrolizumab vs. 52% in the control group (HR = 0.61, P = .035), showing a statistically significant improvement.
• The addition of pembrolizumab led to a higher incidence of grade ≥3 adverse events, including anemia and wound infection, compared to the control group.
• The study suggests pembrolizumab with radiation and surgery is a promising new treatment for stage III undifferentiated pleomorphic sarcoma and pleomorphic or dedifferentiated liposarcoma.
Lupin Receives Tentative USFDA Approval for Generic Raltegravir Tablets
• Lupin has received tentative approval from the USFDA for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg, a generic version of Merck's Isentress HD.
• Lupin is the exclusive first-to-file for this product, potentially granting them 180-day exclusivity in the market.
• Raltegravir Tablets are indicated for use in combination with other antiretroviral agents for treating HIV-1 infection in adults and pediatric patients weighing at least 40 kg.
• The annual sales for Raltegravir Tablets USP, 600 mg (RLD Isentress HD) in the U.S. market were approximately USD 36 million as of September 2024.
Tirzepatide's Benefits and Risks Re-Evaluated After UK Death
• Tirzepatide's safety and benefits are under scrutiny following a reported death in the UK, prompting a re-evaluation of its risk profile.
• Clinical trial data involving approximately 10,000 participants suggest tirzepatide has acceptable safety with benefits like weight loss and diabetes prevention.
• Experts emphasize the need for vigilance and comprehensive data analysis, cautioning against drawing conclusions from single case reports.
• Tirzepatide's common side effects include nausea, diarrhea, vomiting, and constipation, while uncommon issues such as acute pancreatitis can occur.
Sacituzumab Tirumotecan (Sac-TMT) Approved in China for Advanced TNBC
• Kelun-Biotech's Sacituzumab tirumotecan (Sac-TMT) has received marketing approval in China for treating advanced or metastatic triple-negative breast cancer (TNBC).
• The approval is based on the Phase III OptiTROP-Breast01 trial, which showed Sac-TMT significantly improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy.
• Sac-TMT is the first domestically developed TROP2-directed antibody-drug conjugate (ADC) to be fully approved for marketing in China.
• Kelun-Biotech is also pursuing approval for Sac-TMT as a monotherapy for EGFR-mutant non-small cell lung cancer (NSCLC) after EGFR-TKI therapy.
RSV Therapeutic Pipeline Shows Promise with Novel Therapies and Clinical Advancements
• Over 50 companies are actively developing more than 50 therapeutic options for Respiratory Syncytial Virus (RSV) treatment, indicating a robust pipeline.
• GSK's Arexvy vaccine demonstrated encouraging Phase III results, preventing lower respiratory tract disease (LRTD) in older adults across three RSV seasons.
• Merck's clesrovimab showed positive topline results in a Phase IIb/III trial as a preventive treatment for RSV in infants, highlighting potential for vulnerable populations.
Schizophrenia Clinical Trial Pipeline Boasts 60+ Drugs Under Development
• The schizophrenia treatment landscape is expanding with over 60 drugs in active development, driven by increased R&D and innovative therapies.
• Key players like Sumitomo Pharma, Boehringer Ingelheim, and Reviva Pharmaceuticals are advancing novel antipsychotics and personalized medicine approaches.
• Recent progress includes positive Phase III trial results for brilaroxazine and LY03020's IND approval in China, signaling potential new treatment options.
• COBENFY, a first-in-class muscarinic agonist, received FDA approval, marking a significant advancement in schizophrenia treatment after 35 years.
Belzutifan Shows Sustained Efficacy in VHL-Associated CNS Hemangioblastomas
• Belzutifan demonstrates meaningful antitumor activity in von Hippel-Lindau (VHL) disease-associated central nervous system (CNS) hemangioblastomas, with efficacy sustained over three years.
• In a Phase II trial, 44% of patients with VHL-associated CNS hemangioblastomas achieved an objective response with belzutifan, and 46% experienced stable disease.
• The median duration of response to belzutifan was not reached, indicating a prolonged benefit for patients with VHL-related CNS tumors.
• Belzutifan's safety profile showed manageable adverse events, supporting its role as a systemic treatment option for VHL disease-related CNS hemangioblastomas.
FDA Advisory Committee Recommends Against Checkpoint Inhibitors for Certain Gastroesophageal Cancers
• The ODAC voted against the risk-benefit profile of PD-1 inhibitors for first-line treatment of HER2-negative, MSS gastric/GEJ adenocarcinoma with PD-L1 expression under 1.
• Similar concerns were raised regarding esophageal squamous cell carcinoma, with the committee voting against anti-PD-1 therapies in patients with PD-L1 expression less than 1.
• The decisions were based on data from trials like CheckMate 649, KEYNOTE-859, and RATIONALE-305, which suggested limited benefit in PD-L1-low subgroups.
• The committee emphasized the need for consistent treatment strategies and acknowledged the challenges of PD-L1 testing variability and interpretation.
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