MedPath

Clinical Trial News

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

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

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

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.

MacroGenics' Vobra Duo Shows Promise in Metastatic Castration-Resistant Prostate Cancer

  • MacroGenics announced updated Phase 2 TAMARACK study data for vobramitamab duocarmazine (vobra duo) in metastatic castration-resistant prostate cancer (mCRPC).
  • The study demonstrated encouraging antitumor activity with vobra duo, reflected in a 6-month landmark radiographic progression-free survival (rPFS) rate of approximately 70%.
  • Patients in the TAMARACK study remained on vobra duo for a median of six doses, suggesting improved tolerability compared to prior studies.
  • MacroGenics anticipates mature median rPFS data in early 2025 to inform future development plans and potential partnerships.

Akeso's Bispecific Antibodies Show Promise in Lung and Colorectal Cancers

  • Akeso's ivonescimab, a PD-1/VEGF bispecific antibody, gains approval in China for EGFR-mutated NSCLC and shows significant benefits in PD-L1 positive NSCLC compared to pembrolizumab.
  • Ligufalimab, a CD47 monoclonal antibody, enters Phase III trials for head and neck squamous cell carcinoma, marking the first CD47 mAb in Phase III for solid tumors.
  • Ivonescimab, combined with FOLFOXIRI, demonstrates high anti-tumor activity in first-line treatment of MSS/pMMR metastatic colorectal cancer, with a 88.2% objective response rate.
  • Akeso is advancing a diverse pipeline of innovative therapies, including bispecific antibodies and ADCs, with multiple Phase III trials underway across various cancer types.

FDA Approves New Therapies for Multiple Sclerosis and Eczema

  • The FDA has approved Roche's Ocrevus Zunovo, an injectable formulation of its multiple sclerosis therapy, offering a more accessible option for patients.
  • Eli Lilly's Ebglyss has received FDA approval for treating eczema in patients aged 12 and older, expanding therapeutic options for this age group.
  • The World Health Organization (WHO) has cleared Bavarian Nordic's mpox vaccine and initiated a distribution scheme targeting vulnerable populations in low-income countries.

Trending News

1

Lilly's Once-Weekly Insulin Efsitora Alfa Achieves Non-Inferiority in Phase 3 Trials, Reducing Injection Burden by 300 Doses Annually

2 days ago
2

Otsuka Pharmaceutical Secures Global Rights to HBM7020 BCMAxCD3 Bispecific T-Cell Engager for Autoimmune Diseases

2 days ago
3

Nuvalent to Present Pivotal Data for ROS1-Selective Inhibitor Zidesamtinib in Advanced Lung Cancer

a day ago
4

Novo Nordisk's Mim8 Shows Safe Direct Switch from Emicizumab in Phase 3b Hemophilia A Trial

2 days ago
5

Japanese Startup's Urine-Based Cancer Test Detects Stage 0 Lung Cancer in Hokkaido Pilot Study

3 days ago
6

Roche's NXT007 Achieves Zero Bleeds in Phase I/II Hemophilia A Trial, Advances to Phase III

2 days ago
7

Glenmark Launches Tevimbra, First Immuno-Oncology Drug in India for Lung and Esophageal Cancer Treatment

15 hours ago
8

Carisma Therapeutics and OrthoCellix Announce $25M Merger to Advance Phase 3 Knee Cartilage Therapy

a day ago
9

EMA Recommends Approval of Alvotech's Biosimilar to Eylea for Eye Disorders

2 days ago
10

Lundbeck's Lu AG13909 Receives Orphan Drug Designation for Congenital Adrenal Hyperplasia Treatment

18 hours ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy