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Clinical Trial News

Toripalimab Combo Shows Superior Survival Over Sunitinib in Renal Cell Carcinoma

A phase 3 trial demonstrates that toripalimab combined with axitinib significantly improves progression-free survival in patients with advanced renal cell carcinoma compared to sunitinib monotherapy, marking a significant advancement in treatment options.

Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer

NCT04394975CompletedPhase 3
Shanghai Junshi Bioscience Co., Ltd.
Posted 8/20/2020

IoMT Set to Transform Healthcare with $486B Market Projection by 2031

  • The Internet of Medical Things (IoMT) market is experiencing rapid growth, with projections showing an increase from $99.58 billion in 2022 to $486.34 billion by 2031.
  • IoMT technology enables healthcare providers to streamline device management, improve information flow, and enhance patient care through connected medical devices and integrated data systems.
  • The implementation of IoMT solutions offers critical benefits including automated device protection, seamless data transfer, unified dashboard messaging, and practical insights for medical professionals.

EMA Recommends Nivolumab and Ipilimumab Combination for dMMR/MSI-H Metastatic Colorectal Cancer

  • The EMA's CHMP has recommended nivolumab plus ipilimumab for treating dMMR or MSI-H metastatic colorectal cancer in adults after prior chemotherapy.
  • This combination therapy targets tumors with mismatch repair deficiency or high microsatellite instability, addressing a critical unmet need.
  • The recommendation expands the indications for both nivolumab (Opdivo) and ipilimumab (Yervoy) in the European Union.
  • This approval marks a significant advancement in treating this specific subset of colorectal cancer patients who have limited treatment options.

Novel BCMA-Targeted Therapies and Emerging Agents Transform Treatment Landscape for Relapsed/Refractory Multiple Myeloma

CAR-TDrug Approval
  • BCMA-directed therapies including CAR T-cell products ide-cel and cilta-cel, along with bispecific T-cell engager teclistamab, have demonstrated unprecedented efficacy in heavily pretreated patients with relapsed/refractory multiple myeloma.
  • Emerging bispecific antibodies elranatamab and talquetamab show promising response rates of 61-74% in triple-class refractory patients, offering new treatment options for those who have exhausted conventional therapies.
  • Novel agents including mezigdomide (a CELMoD), purinostat mesylate (HDAC inhibitor), and bispecific CS1-BCMA CAR T cells are expanding therapeutic options with manageable safety profiles.
  • The treatment paradigm is shifting toward earlier use of BCMA-targeted therapies and novel combinations, as patients increasingly become refractory to multiple drug classes including immunomodulators, proteasome inhibitors, and anti-CD38 antibodies.

Selinexor and Backbone Treatments of Multiple Myeloma Patients

NCT02343042Active, Not RecruitingPhase 1
Karyopharm Therapeutics Inc
Posted 10/1/2015

Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed And/or Refractory Multiple Myeloma

NCT04835129RecruitingPhase 2
Medical College of Wisconsin
Posted 1/10/2022

EU Unveils Ambitious Pharmaceutical Reform: Single Market Plan Sparks Industry Debate

  • The European Commission has proposed a major overhaul of pharmaceutical legislation, aiming to create a unified single market for medicines across the EU to improve patient access and market efficiency.
  • The reform includes controversial changes to market exclusivity periods, reducing standard protection from 10 to 8 years, while offering extensions up to 12 years for companies meeting specific criteria.
  • The proposal streamlines drug approval processes, cutting EMA review time to 180 days and introducing measures for emergency drug manufacturing and antimicrobial resistance initiatives.

Hydrogel Implant Eliminates Brain Cancer Recurrence in Mice

  • Researchers developed a hydrogel containing chemotherapy drug paclitaxel and aCD47 antibodies, preventing glioblastoma recurrence in mice.
  • The hydrogel is implanted post-surgery, delivering targeted chemo- and immunotherapy directly to the brain cavity.
  • Mice treated with the dual-action hydrogel showed a 100% survival rate, suggesting a potential 'vaccine effect' against glioblastoma.
  • This innovative approach offers renewed hope for improving survival rates in patients with aggressive brain cancers.

One-Week Elderberry Juice Treatment Increases Postprandial Carbohydrate Oxidation

A pilot study found that consuming 100% elderberry juice for one week significantly increased postprandial carbohydrate oxidation in overweight and obese adults, without affecting serum glucose or insulin levels. The study suggests elderberry juice could influence metabolic flexibility, though further research is needed to confirm these findings.

FDA Approves Biogen's Qalsody, First Treatment Targeting Genetic Cause of ALS

  • The FDA has approved Qalsody (tofersen) from Biogen, the first treatment targeting a genetic cause of amyotrophic lateral sclerosis (ALS).
  • Qalsody is indicated for adults with ALS who have a mutation in the superoxide dismutase 1 (SOD1) gene, representing about 2% of ALS cases.
  • The approval was based on the reduction in plasma neurofilament light chain, a marker of neurodegeneration, observed in patients treated with Qalsody.
  • This approval marks a pivotal moment in ALS research, establishing neurofilament as a surrogate marker reasonably likely to predict clinical benefit in SOD1-ALS.

FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

• The FDA granted traditional approval to Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive metastatic castration-resistant prostate cancer patients who have received androgen receptor pathway inhibition and taxane-based chemotherapy.
• In the pivotal VISION trial, Pluvicto plus best standard of care demonstrated a statistically significant improvement in overall survival (15.3 vs 11.3 months) compared to best standard of care alone, with a hazard ratio of 0.62.
• The most common adverse reactions included fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation, with serious adverse reactions occurring in 36% of patients receiving the radioligand therapy.

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

NCT03511664CompletedPhase 3
Endocyte
Posted 5/29/2018

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC

NCT04720157Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 6/9/2021

177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

NCT04689828Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 6/15/2021

Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

NCT04647526Active, Not RecruitingPhase 3
POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Posted 2/25/2021

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