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Clinical Trial News

IO102-IO103 Cancer Vaccine Plus Pembrolizumab Shows Promise in Head and Neck Cancer

  • A phase 2 trial combining IO102-IO103 cancer vaccine with pembrolizumab demonstrated a 44.4% partial response rate in advanced squamous cell carcinoma of the head and neck (SCCHN).
  • The combination therapy's safety profile was consistent with pembrolizumab alone, with some injection site reactions, suggesting a manageable safety profile.
  • Early data indicate that the vaccine activates T cells against IDO-positive and PD-L1–positive cells, potentially enhancing the immune response in the tumor microenvironment.
  • These findings support further investigation in larger studies to confirm the efficacy and potential of IO102-IO103 plus pembrolizumab in SCCHN.

ESMO 2024: New Leadership and Groundbreaking Developments in Oncology Research and Patient Care

  • ESMO President Prof Andres Cervantes highlights the organization's evolution into a comprehensive support network for oncologists, announcing new initiatives including AI & Digital Oncology Congress 2025.
  • Significant advances in oncofertility research reveal pregnancy after breast cancer is feasible, leading to new fertility preservation laws and guidelines for cancer patients.
  • Whole Genome Sequencing emerges as a transformative tool in personalized cancer care, with Prof Serena Nik-Zainal demonstrating its potential for identifying unique mutational signatures in individual tumors.

Dermatology Experts Highlight Advances in Treatment and Clinical Trial Diversity

• Experts at the Skin of Color Update 2024 emphasized the importance of diversity in clinical trials to address health disparities and improve data for all patient populations. • Recent FDA approvals of topical therapies like roflumilast and tapinarof for atopic dermatitis and other conditions were highlighted for their efficacy and safety. • Advances in biologic therapies, including bimekizumab, secukinumab, and nemolizumab, offer new treatment options for conditions like psoriasis, hidradenitis suppurativa and prurigo nodularis. • The FDA's Diversity Action Plan (DAP) aims to increase the enrollment of underrepresented groups in clinical trials, ensuring treatments are effective across diverse populations.

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501679CompletedPhase 3
Galderma R&D
Posted 8/11/2020

This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

NCT03713619CompletedPhase 3
Novartis Pharmaceuticals
Posted 1/31/2019

Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT04211363CompletedPhase 3
Arcutis Biotherapeutics, Inc.
Posted 12/20/2019

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

NCT03956355CompletedPhase 3
Organon and Co
Posted 5/21/2019

Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

NCT04973228CompletedPhase 3
Arcutis Biotherapeutics, Inc.
Posted 7/8/2021

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03410992CompletedPhase 3
UCB Biopharma SRL
Posted 2/5/2018

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

NCT03713632CompletedPhase 3
Novartis Pharmaceuticals
Posted 2/25/2019

Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT04211389CompletedPhase 3
Arcutis Biotherapeutics, Inc.
Posted 12/17/2019

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03370133CompletedPhase 3
UCB Biopharma SRL
Posted 12/6/2017

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)

NCT03983980CompletedPhase 3
Organon and Co
Posted 6/6/2019

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03412747CompletedPhase 3
UCB Biopharma SRL
Posted 1/26/2018

FDA Approves Kisunla (donanemab-azbt) for Early-Stage Alzheimer's Disease

  • The FDA has approved Kisunla (donanemab-azbt) for treating early-stage Alzheimer's, marking a significant advancement in disease management.
  • Kisunla, an amyloid-directed antibody, targets and helps remove amyloid plaques in the brain, which are believed to contribute to cognitive decline.
  • Clinical trials showed that a significant percentage of patients achieved undetectable amyloid plaque levels, allowing them to discontinue treatment.
  • Safety concerns include ARIA, a potential side effect requiring careful monitoring through MRI and symptom awareness.

Advancements in Ocular Therapies: Updates on Dry Eye, AMD, and Myopia Management

• Aldeyra Therapeutics resubmitted its NDA for reproxalap, targeting dry eye disease symptoms with both acute and chronic activity demonstrated in trials. • Aviceda Therapeutics completed enrollment for its Phase 2b SIGLEC study, evaluating AVD-104 for geographic atrophy secondary to age-related macular degeneration. • Ocular Therapeutix accelerates the SOL-1 Phase 3 trial of Axpaxli for wet AMD, expecting topline data in Q4 2025.

OcuDyne's OPTiC System Shows Promise in Geographic Atrophy Pilot Study

  • OcuDyne's OPTiC System pilot study demonstrates procedural feasibility for ophthalmic artery angioplasty in treating vascular lesions linked to geographic atrophy.
  • The study showed subjective visual function improvement in BCVA, MNRead acuity, and reading speed, alongside objective evidence of visual function preservation.
  • No device-related adverse effects were reported, with ocular adverse events being transient and resolving without treatment.
  • OcuDyne plans to develop further data to support regulatory approval pathways for the OPTiC System following positive trial results.

FDA Approves Eli Lilly's Ebglyss for Eczema Treatment

  • Eli Lilly's Ebglyss (lebrikizumab) has received FDA approval for treating moderate-to-severe atopic dermatitis (eczema).
  • Clinical trials showed that 38% of patients achieved clear or almost-clear skin with Ebglyss at 16 weeks, compared to 12% with placebo.
  • Ebglyss offers a new treatment option for individuals whose eczema is not adequately controlled with topical therapies.

Aclarubicin Shows Promise as Less Toxic Chemotherapy for Childhood Cancers

  • Aclarubicin, an anthracycline chemotherapy not currently available in the U.S., is showing promise as a less toxic alternative to existing treatments for childhood cancers.
  • Preclinical studies indicate that aclarubicin effectively kills cancer cells while minimizing long-term side effects such as heart problems and secondary cancers.
  • Researchers at Seattle Children's are planning clinical trials to evaluate aclarubicin's safety and efficacy, potentially importing the drug from China for testing.
  • Aclarubicin's unique mechanism of action, primarily damaging chromatin rather than DNA, may reduce cardiotoxic effects compared to drugs like doxorubicin.

FDA Updates Veozah Label with Warning for Rare but Serious Liver Injury

  • The FDA has issued a warning for Veozah (fezolinetant) regarding rare but serious liver injury in patients using the drug for hot flashes due to menopause.
  • The updated label includes recommendations for increased frequency of liver blood testing during treatment, specifically monthly for the first two months.
  • Patients are advised to immediately stop Veozah and contact their healthcare provider if they experience signs and symptoms of liver injury.
  • The FDA's decision was prompted by a postmarketing report of a patient exhibiting elevated liver blood test values and liver injury symptoms after approximately 40 days of treatment.

Taletrectinib Shows Promise in ROS1-Positive NSCLC: Nuvation Bio Announces Positive Phase 2 Data

• Taletrectinib demonstrated an 89% tumor shrinkage rate in TKI-naïve patients with ROS1-positive NSCLC, showcasing its high efficacy. • The drug achieved a median duration of response of 44 months and progression-free survival of 46 months in TKI-naïve patients. • Taletrectinib exhibited a favorable safety profile with a low incidence of neurologic treatment-emergent adverse events. • Nuvation Bio plans to submit an NDA to the FDA in Q4 2024, aiming for a U.S. launch in 2025.

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

NCT04919811RecruitingPhase 2
Nuvation Bio Inc.
Posted 9/1/2021

A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

NCT04395677Active, Not RecruitingPhase 2
AnHeart Therapeutics Inc.
Posted 7/7/2020

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