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Clinical Trial News

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.

Retifanlimab Plus Chemotherapy Improves PFS in Advanced Anal Cancer

  • The POD1UM-303 trial demonstrated that adding retifanlimab to carboplatin and paclitaxel significantly improved progression-free survival (PFS) in patients with recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
  • Patients receiving retifanlimab plus chemotherapy experienced a median PFS of 9.3 months compared to 7.4 months with placebo plus chemotherapy, showing a statistically significant improvement.
  • The combination therapy also led to a higher overall response rate (ORR) and a longer duration of response (DOR) compared to placebo plus chemotherapy in this patient population.
  • Interim overall survival (OS) data suggest a trend towards improved survival with retifanlimab, indicating 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 Apple AirPods Pro 2 as Over-the-Counter Hearing Aid

  • The FDA has authorized Apple's AirPods Pro 2 as an over-the-counter (OTC) hearing aid, marking the first approval of its kind for a software-driven consumer product.
  • The new hearing aid feature is designed for adults 18 and older with mild to moderate hearing impairment, offering a clinical-grade solution.
  • Users can conduct a hearing test via the AirPods Pro 2 and a paired iPhone to create a personalized sound profile based on detected hearing loss.
  • Apple is also introducing a hearing protection mode to help protect users' hearing in loud environments by enabling passive noise isolation.

Atezolizumab Following Vemurafenib/Cobimetinib Shows OS Trend in Melanoma

  • Final data from the phase 2 ImmunoCobiVem trial showed a trend toward improved overall survival (OS) with atezolizumab after vemurafenib plus cobimetinib in BRAF V600–positive melanoma.
  • Median OS was 49.6 months with atezolizumab vs. 40.2 months with continuous vemurafenib/cobimetinib, though the difference was not statistically significant (HR, 1.17; P = .94).
  • Progression-free survival (PFS1) was significantly longer with continuous targeted therapy (13.0 months) compared to switching to atezolizumab (5.9 months; HR, 0.61; P = .006).
  • No subgroups were identified where a targeted therapy run-in provided clinical benefit, suggesting limited advantage in early switching to immunotherapy.

Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

NCT02902029CompletedPhase 2
University Hospital, Essen
Posted 11/1/2016

Perioperative Nivolumab Demonstrates Significant EFS Benefit in Resectable NSCLC

• Perioperative nivolumab significantly improved event-free survival (EFS) compared to placebo in patients with resectable non-small cell lung cancer (NSCLC). • The CheckMate 77T study showed a median EFS of 40.1 months with nivolumab versus 17.0 months with placebo, demonstrating a clinically meaningful improvement. • Patients achieving pathologic complete response (pCR) with nivolumab experienced a notable EFS benefit compared to those receiving placebo. • ctDNA clearance during neoadjuvant therapy was indicative of higher pCR rates and improved EFS, further supporting nivolumab's efficacy.

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

ICMR Partners with Industry for First-in-Human Trials of Novel Therapies

• ICMR has formalized agreements with multiple sponsors to advance four promising molecules into first-in-human clinical trials, marking a significant step for pharmaceutical innovation in India. • The collaborations include research into a small molecule for multiple myeloma, a Zika vaccine, a seasonal influenza vaccine, and CAR-T cell therapy for chronic lymphocytic leukemia. • This initiative aims to establish India as a leader in the clinical development of pharmaceutical agents through strategic public-private partnerships, enhancing the nation's capacity for early-phase clinical trials. • The ICMR Network for phase 1 clinical trials includes four institutions across India, supported by a central coordinating unit, to ensure smooth and effective trial operations.

Early Atezolizumab Switch After Vemurafenib/Cobimetinib Shows OS Improvement in BRAF V600-Positive Melanoma

  • Switching to atezolizumab after a vemurafenib/cobimetinib run-in showed improved overall survival (OS) in BRAF V600-positive melanoma, though not statistically significant.
  • Median OS was 49.6 months with the early switch to atezolizumab, compared to 40.2 months with continuous targeted therapy.
  • Progression-free survival (PFS1) was longer with continuous targeted therapy, indicating better early tumor control with this approach.
  • No specific subgroups were identified that benefited from the targeted therapy run-in, suggesting limited predictive value.

Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

NCT02902029CompletedPhase 2
University Hospital, Essen
Posted 11/1/2016

Pembrolizumab Shows Sustained DFS Benefit in Muscle-Invasive Urothelial Carcinoma

• Extended follow-up from the AMBASSADOR trial reveals pembrolizumab significantly improves disease-free survival (DFS) in high-risk muscle-invasive urothelial carcinoma (MIUC). • After a median of 45 months, pembrolizumab demonstrated a median DFS of 29.6 months compared to 14.2 months with observation alone. • The DFS benefit was observed regardless of PD-L1 expression and lymph node status, supporting pembrolizumab as a therapeutic option. • Common recurrence sites included lymph nodes, lung, bone, and liver, highlighting the need for comprehensive monitoring strategies.

Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer

NCT03244384Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 11/3/2017

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.

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