Clinical Trial News
Enfortumab Vedotin and Pembrolizumab Show Significant Survival Benefit in Urothelial Cancer Treatment
A recent study, EV-302, demonstrates that the combination of enfortumab vedotin and pembrolizumab significantly improves progression-free survival and overall survival in patients with previously untreated locally advanced or metastatic urothelial cancer, compared to standard platinum-based chemotherapy.
ACELYRIN's Izokibep Shows Sustained Efficacy in Hidradenitis Suppurativa Phase 2b Trial
- ACELYRIN's izokibep demonstrated sustained Hidradenitis Suppurativa Clinical Response (HiSCR) through 32 weeks in a Phase 2b trial, with a third of patients achieving HiSCR100.
- Patients switching from placebo to izokibep at week 16 experienced similar response rates in HiSCR, draining tunnels, and skin pain as those starting earlier.
- The study indicated clinically meaningful improvements in quality of life, marked by reductions in draining tunnels and skin pain, with a favorable safety profile.
- Topline data from an ongoing phase 3 trial in HS is expected by the end of 2024, with a confirmatory phase 3 trial planned.
Highlighted Clinical Trials:
ACELYRIN Inc.
Posted 5/5/2022
Acelyrin's Izokibep Meets Primary Endpoint in Phase 2b/3 Psoriatic Arthritis Trial
- Acelyrin's izokibep demonstrated high statistical significance in meeting the primary endpoint of ACR50 at week 16 versus placebo in a Phase 2b/3 trial for psoriatic arthritis.
- The study showed robust clinical responses in ACR70 and PASI100, with a favorable safety profile consistent with the IL-17A class, and a low study discontinuation rate.
- Izokibep achieved clinically meaningful resolution in patients with a high burden of enthesitis, an effect not previously reported by other agents.
- The results support izokibep's potential as a differentiated treatment, with the 160 mg Q2W dose showing higher clinical responses than approved IL-17A agents.
Highlighted Clinical Trials:
AOA Diagnostics Developing Novel Blood Test for Early Ovarian Cancer Detection
- AOA Diagnostics, a women-founded startup in Denver, is developing a blood test for early ovarian cancer detection, addressing a critical unmet need.
- The test aims to improve survival rates by enabling earlier diagnosis, as 80% of ovarian cancer cases are currently detected at late stages.
- AOA Diagnostics has secured funding and established a lab in Colorado, collaborating with UCHealth and other institutions to advance the research.
- A clinical study is underway to validate the early detection tool, offering hope for improved women's healthcare and cancer outcomes.
Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) Regimen Shows Significant Benefit in Relapsed/Refractory Multiple Myeloma
- The DREAMM-7 study demonstrated that belantamab mafodotin, bortezomib, and dexamethasone (BVd) significantly improved progression-free survival in relapsed/refractory multiple myeloma patients compared to daratumumab, bortezomib, and dexamethasone (DVd).
- Median progression-free survival was 36.6 months in the BVd arm versus 13.4 months in the DVd arm (HR = 0.41; P < .0001), with consistent benefits across subgroups, including lenalidomide-refractory and high-risk cytogenetic myeloma.
- An early, strong trend toward better overall survival was observed with BVd (HR = 0.57; P = .00049), alongside a doubling in response rates and undetectable measurable residual disease.
- While ocular adverse effects were more frequent with BVd, they were generally manageable and reversible, suggesting BVd as a potential new standard of care in second-line or later relapsed/refractory multiple myeloma.
Highlighted Clinical Trials:
GlaxoSmithKline
Posted 5/7/2020
GlaxoSmithKline
Posted 10/1/2020
Recursion's AI-Discovered Cancer Treatment REC-1245 Receives FDA Clearance for Phase 1/2 Trial
- Recursion's REC-1245, an AI-discovered drug for biomarker-enriched solid tumors and lymphoma, has received FDA clearance for a Phase 1/2 clinical trial.
- The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential efficacy of REC-1245 as a monotherapy.
- REC-1245 is a potent and selective RBM39 degrader, potentially offering a novel therapeutic approach for tumors resistant to conventional treatments.
- Recursion estimates the addressable patient population for REC-1245 to be over 100,000 in the US and EU5 countries.
Subcutaneous Nivolumab Offers a Promising Alternative for Kidney Cancer Treatment
A clinical trial reveals that subcutaneous nivolumab, an injectable form of immunotherapy, is as effective as the intravenous version for treating advanced kidney cancer, with the added benefits of reduced treatment time and increased convenience for patients.
Promontory Therapeutics Completes Enrollment in Phase 2 Trial of PT-112 for Late-Stage Metastatic Prostate Cancer
- Promontory Therapeutics has completed enrollment of 109 patients in its Phase 2 trial of PT-112 for metastatic castration-resistant prostate cancer (mCRPC) across 32 clinical sites in the US and France.
- PT-112, the first small-molecule conjugate of pyrophosphate in clinical oncology development, works by inhibiting ribosomal biogenesis to induce immunogenic cell death in "immune-cold" prostate cancer.
- The study targets heavily pre-treated patients who have received at least three prior therapies, with topline safety and efficacy results expected in late 2024 following planned FDA meetings.
Highlighted Clinical Trials:
Promontory Therapeutics Inc.
Posted 7/1/2014
FDA to Convene Advisory Committee for Eli Lilly's Alzheimer's Drug Donanemab
- The FDA has announced plans to convene a Peripheral and Central Nervous System Drugs Advisory Committee to review donanemab's efficacy and safety profile before making a final approval decision.
- Donanemab's TRAILBLAZER-ALZ 2 trial employed innovative biomarker strategies, using both Amyvid® and Tauvid™ PET scans to identify early-stage patients with confirmed amyloid plaques most likely to benefit from treatment.
- Experts view anti-amyloid therapies like donanemab as just the first line of defense, with approximately 75% of Alzheimer's drugs in development now exploring novel targets related to aging pathways including inflammation and vascular dysfunction.
Doxycycline Post-Exposure Prophylaxis Shows Promise in Reducing STIs in San Francisco
- Doxycycline post-exposure prophylaxis (doxyPEP) has led to a significant reduction in sexually transmitted infections (STIs) among gay and bisexual men and transgender people in San Francisco.
- Real-world data from San Francisco clinics and population-wide analyses align with clinical trial results, indicating doxyPEP's effectiveness in reducing chlamydia and syphilis.
- While doxyPEP demonstrated a substantial impact on chlamydia and syphilis, its effect on gonorrhea was less pronounced, potentially due to drug resistance or adherence issues.
- San Francisco's early adoption of doxyPEP guidelines has positioned it as a leader in STI prevention, with other cities and healthcare providers potentially following suit.