MedPath

Clinical Trial News

Hypofractionated Radiotherapy Shows Equivalence to Standard for Locoregional Breast Cancer

  • The HypoG-01 trial demonstrates that a 3-week hypofractionated radiotherapy regimen is equivalent to a 5-week normofractionated regimen for locoregional breast cancer.
  • The study included 1,265 patients and found no significant difference in lymphoedema onset, locoregional relapse-free survival, or overall survival between the two regimens.
  • The 3-week hypofractionated course is now a standard of care for women with node-invasive breast cancer, offering convenience and reduced burden.
  • This academic study highlights France's capability to conduct impactful clinical trials, providing direct benefits for patients and healthcare systems.

Terns Pharmaceuticals Gains Attention in Weight Loss Market Following Promising Phase 1 Data

  • Terns Pharmaceuticals' stock is gaining traction as a potential investment opportunity in the weight loss sector, following positive Phase 1 results for its drug candidate, TERN-601.
  • TERN-601 demonstrated an average weight loss of 5.5% in patients after 28 days at the highest dose, suggesting it could be competitive with existing treatments.
  • Terns Pharmaceuticals is well-funded with $225 million in cash reserves, supporting further development of TERN-601 and potentially attracting additional investment.
  • The company plans to advance TERN-601 into Phase 2 trials in 2025, marking a significant milestone in its development as an oral anti-obesity treatment.

Biomarker-Guided Nivolumab Improves Cost-Effectiveness in MSS/pMMR Metastatic Colorectal Cancer

  • Biomarker-guided selection for nivolumab in microsatellite stable (MSS)/proficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC) may enhance cost-effectiveness.
  • A study using METIMMOX-1 data showed that tumor mutational burden (TMB), target lesion reduction, and C-reactive protein could identify patients benefiting from nivolumab.
  • Selecting patients with TMB > 8.0 mut/MB significantly reduced the incremental cost-effectiveness ratio (ICER) compared to treating all MSS/pMMR mCRC patients.
  • Prospective validation of biomarker-guided strategies, particularly TMB, is warranted to confirm these findings and their applicability in diverse healthcare settings.

Pembrolizumab Plus Chemotherapy Demonstrates DFS Benefit in dMMR Endometrial Cancer Subgroup

  • A subgroup of patients with dMMR high-risk endometrial cancer showed improved disease-free survival (DFS) with adjuvant pembrolizumab plus chemotherapy.
  • In dMMR tumors, the 2-year DFS rates were 92% with pembrolizumab versus 80% with placebo, indicating a clinically meaningful benefit.
  • The overall trial population did not show a DFS improvement, highlighting the importance of MMR status as a predictive biomarker.
  • The combination's safety profile was consistent with known checkpoint inhibitors, with manageable adverse events reported.

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

Pembrolizumab Plus Chemotherapy Demonstrates Overall Survival Benefit in Early TNBC

  • Neoadjuvant pembrolizumab combined with chemotherapy, followed by adjuvant pembrolizumab, significantly improves overall survival in early-stage triple-negative breast cancer (TNBC).
  • The KEYNOTE-522 trial showed a 34% reduction in the risk of death with the pembrolizumab regimen compared to placebo, with a hazard ratio of 0.66 (95% CI, 0.50-0.87; P = .00150).
  • At a median follow-up of 75.1 months, the 5-year overall survival rate was 86.6% in the pembrolizumab arm versus 81.7% in the placebo arm.
  • Patients achieving pathological complete response (pCR) experienced an overall survival benefit, irrespective of the treatment arm.

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

NCT03036488Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 3/7/2017

Immunotherapy Combinations Improve Survival in Aggressive Cancers: TNBC and Bladder Cancer

  • Phase III trials show that combining immunotherapy drugs with chemotherapy improves survival in triple-negative breast cancer (TNBC) and muscle-invasive bladder cancer.
  • Pembrolizumab combined with chemotherapy reduces the risk of cancer recurrence and improves overall survival in high-risk early-stage TNBC patients.
  • Durvalumab with chemotherapy increases the cure rate in patients with muscle-invasive bladder cancer, marking a significant advancement in treatment.
  • These findings establish new standards of care for these aggressive cancers, offering improved outcomes for patients.

Pembrolizumab Plus Chemotherapy Improves Overall Survival in Early TNBC

  • Neoadjuvant pembrolizumab with chemotherapy, followed by adjuvant pembrolizumab, significantly improved overall survival (OS) in early-stage triple-negative breast cancer (TNBC).
  • The KEYNOTE-522 trial showed a 34% reduction in the risk of death with the pembrolizumab regimen compared to placebo (HR, 0.66; P = .00150).
  • At a median follow-up of 75.1 months, the 5-year OS rate was 86.6% in the pembrolizumab arm versus 81.7% in the placebo arm.
  • Patients achieving pathological complete response (pCR) experienced an OS benefit, irrespective of the treatment arm.

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

NCT03036488Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 3/7/2017

Retifanlimab Plus Chemotherapy Improves Outcomes in Advanced Anal Cancer

  • The POD1UM-303 trial showed that adding retifanlimab to carboplatin and paclitaxel significantly improved progression-free survival in patients with recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
  • Patients receiving retifanlimab plus chemotherapy had a median PFS of 9.3 months compared to 7.4 months with chemotherapy alone (HR, 0.63; P = .0006).
  • The combination therapy also demonstrated a higher overall response rate (56% vs 44%) and a longer duration of response (14.0 months vs 7.2 months).
  • Interim overall survival data favored the retifanlimab arm, suggesting a potential new standard of care for advanced SCAC.

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

NCT04472429Active, Not RecruitingPhase 3
Incyte Corporation
Posted 1/12/2021

FDA Approves Roche's Subcutaneous Multiple Sclerosis Treatment and Eli Lilly's Eczema Drug

  • The FDA has approved Roche's subcutaneous injection for multiple sclerosis, offering an alternative to intravenous administration and potentially expanding treatment options.
  • Eli Lilly's new eczema drug has received FDA approval for use in adults and children over 12, providing a new therapeutic option for this patient population.
  • Walgreens Boots Alliance will pay $106.8 million to resolve prescription billing fraud charges involving false claims to Medicare and Medicaid from 2009 to 2020.

WHO Prequalifies MVA-BN Vaccine for Mpox; DOH Warns Against Unauthorized Vaccines

• The World Health Organization (WHO) has prequalified the MVA-BN vaccine, marking the first mpox vaccine to receive this designation, enhancing access in high-need communities. • The MVA-BN vaccine, given as a two-dose injection four weeks apart for adults over 18, shows approximately 82% effectiveness with the full regimen. • The Department of Health (DOH) Region 6 has issued a warning against unauthorized mpox vaccines lacking FDA approval, citing potential safety and efficacy risks. • WHO is also progressing with prequalification and emergency use listing procedures for two other mpox vaccines: LC-16 and ACAM2000.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.