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Clinical Trial News

CAR T-Cell Therapy Expands Beyond Cancer: New Frontiers in Autoimmune Disease Treatment

  • CAR T-cell therapy, historically successful in treating blood cancers, is now being adapted for solid tumors and autoimmune conditions like Multiple Sclerosis and Systemic Lupus Erythematosus.
  • Clinical trials for non-oncology CAR T applications require complex coordination between specialty clinics and established oncology infrastructure, necessitating enhanced safety protocols and medical oversight.
  • Worldwide Clinical Trials is implementing comprehensive patient safety measures, including 24/7 medical monitoring and specialized training programs, to support the expansion of CAR T therapy into new therapeutic areas.

Enzalutamide and Radium-223 Combo Improves Survival in Metastatic Prostate Cancer

  • The combination of enzalutamide and radium-223 significantly improved overall survival in men with castration-resistant prostate cancer and bone metastases.
  • Radiographic progression-free survival was also improved with the combination therapy compared to enzalutamide alone, 19.4 months versus 16.4 months, respectively.
  • The addition of radium-223 to enzalutamide led to a higher incidence of grade 3 or higher drug-related adverse events, increasing from 19% to 28%.
  • The PEACE-3 trial suggests this combination as a potential first-line treatment option for metastatic castration-resistant prostate cancer patients with bone metastases.

Cyramza Plus Lonsurf Fails to Improve Overall Survival in Metastatic Colorectal Cancer

  • The phase 3 IKF-AIO-RAMTAS trial showed that adding Cyramza to Lonsurf did not significantly improve overall survival in heavily pretreated metastatic colorectal cancer patients.
  • Subgroup analysis revealed potential benefits in female patients and those with left-sided tumors, who experienced improved survival outcomes with the Cyramza/Lonsurf combination.
  • While overall survival was not significantly extended, the combination of Cyramza and Lonsurf did demonstrate a significant improvement in progression-free survival.
  • The combination therapy showed a manageable safety profile, though with a higher incidence of treatment-related side effects, particularly those associated with Cyramza.

Updated COVID-19 Vaccines Targeting JN.1 and KP.2 Variants Show Promise

  • Updated COVID-19 vaccines targeting the JN.1 lineage have demonstrated improved immune responses against newer subvariants like KP.2 and KP.3, offering enhanced protection.
  • Regulatory bodies in the US and UK have approved JN.1-specific vaccines from Moderna, Pfizer, and Novavax, with Australia currently evaluating Spikevax and Comirnaty.
  • The FDA has recommended and approved vaccines targeting the KP.2 strain, with minimal difference expected between JN.1 and KP.2 boosters in providing updated protection.
  • While mRNA vaccines are effective, Novavax offers an alternative protein-based option, though its updated booster is not yet under consideration in Australia.

Pembrolizumab Fails to Improve DFS in High-Risk Endometrial Cancer, Shows Promise in dMMR Subgroup

  • A phase 3 trial (ENGOT-en11/GOG-3053/KEYNOTE-B21) showed that adding pembrolizumab to adjuvant chemotherapy did not improve disease-free survival (DFS) in high-risk endometrial cancer patients.
  • However, a subgroup analysis revealed a clinically meaningful DFS benefit for patients with mismatch repair deficient (dMMR) tumors treated with pembrolizumab.
  • In dMMR patients, the 2-year DFS rate was 92% with pembrolizumab versus 80% with placebo, suggesting a potential new treatment approach for this specific population.
  • The combination of pembrolizumab and chemotherapy is already approved for advanced or recurrent endometrial cancer, irrespective of MMR status.

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

NCT04634877Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 1/10/2021

Perioperative Nivolumab and Neoadjuvant Immunotherapy Show Promise in Resectable NSCLC

  • Perioperative nivolumab significantly extends event-free survival (EFS) in resectable non-small cell lung cancer (NSCLC), with a median EFS increase from 17.0 to 40.1 months.
  • Neoadjuvant nivolumab, alone or with ipilimumab, demonstrates durable long-term survival benefits, particularly in patients achieving major pathological response (MPR) or pathological complete response (PCR).
  • Circulating tumor DNA (ctDNA) clearance during neoadjuvant therapy is a potential biomarker, with higher clearance rates observed in patients receiving nivolumab and correlating with improved outcomes.
  • Biomarker analysis suggests PD-L1 positivity may predict better EFS with nivolumab monotherapy, while KRAS co-mutations may benefit more from nivolumab plus ipilimumab combination therapy.

Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer

NCT03158129CompletedPhase 2
M.D. Anderson Cancer Center
Posted 6/16/2017

Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC

NCT02259621Active, Not RecruitingPhase 2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Posted 9/1/2014

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

NCT04025879Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 11/5/2019

De-escalated Therapy Shows Excellent Survival in HR+/HER2+ Breast Cancer

• Patients with HR+/HER2+ early breast cancer achieved excellent survival outcomes with neoadjuvant endocrine therapy or chemotherapy plus trastuzumab and pertuzumab. • Achieving pathological complete response (pCR) was associated with significantly improved event-free survival and overall survival in the WSG-TP II trial. • The addition of adjuvant chemotherapy after pCR did not significantly improve survival outcomes, suggesting potential for chemotherapy de-escalation. • Clinically node-positive status was identified as the only factor significantly associated with worse event-free survival in the analyzed cohort.

SPLASH Trial: Lutetium-177 Demonstrates Efficacy in Advanced Prostate Cancer

  • The SPLASH trial evaluated Lutetium-177-PNT2002 in metastatic castration-resistant prostate cancer (mCRPC) patients who had progressed on ARPI therapy, showing improved radiographic progression-free survival.
  • Lutetium-177-PNT2002 significantly reduced the risk of radiographic progression or death by 29% compared to alternate ARPI therapy, with a hazard ratio of 0.71 (p=0.0088).
  • The treatment demonstrated a favorable safety profile, with fewer Grade 3 or higher adverse events and lower discontinuation rates compared to the ARPI change arm.
  • A high crossover rate (84.6%) from the control arm to Lutetium therapy may have influenced overall survival results, although multiple secondary endpoints favored Lutetium-177-PNT2002.

IMCI Pharmaceuticals Develops Nanoparticle Cannabis Delivery for Medical Use

  • IMCI Pharmaceuticals has developed a novel method to deliver medical cannabis using nanoparticles, offering an alternative to smoking.
  • The iCann platform features three products: sublingual pills for fast action, adhering tablets for long-lasting relief, and swallowed pills for sustained effects.
  • These therapies target chronic ailments like pain, colitis, Alzheimer’s, and autism, with formulations containing varying ratios of THC and CBD.
  • Clinical trials are planned at Hadassah Medical Center to further assess the effects of cannabinoids, with a goal to launch the first product within a year.

Lantheus' SPLASH Trial: пиrogress in Metastatic Castration-Resistant Prostate Cancer

  • Lantheus' SPLASH trial met its primary endpoint, demonstrating a statistically significant improvement in radiographic progression-free survival for patients with mCRPC.
  • The study showed an overall response rate of 38.1% in the пиrogress arm compared to 12.0% in the ARPI switch arm, including a 9.3% complete response rate.
  • пиrogress may offer a new treatment option for mCRPC patients who have progressed on prior androgen receptor pathway inhibitors, addressing an unmet need.

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