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Clinical Trial News

Trastuzumab Deruxtecan Preserves Quality of Life and Delays Pain in HR+/HER2-Low/Ultralow Metastatic Breast Cancer

  • Trastuzumab deruxtecan (T-DXd) maintains global health and quality of life (QOL) in patients with hormone receptor–positive (HR+), HER2-low or -ultralow metastatic breast cancer (MBC).
  • T-DXd significantly reduces the risk of clinically meaningful deterioration in pain compared to treatment of physician’s choice (TPC) in MBC patients.
  • DESTINY-Breast06 trial data showed T-DXd delayed pain deterioration by 15.7 months compared to TPC, highlighting its potential as a new therapeutic option.
  • Gastrointestinal adverse events with T-DXd underscore the importance of antiemetic prophylaxis, though they do not negate overall QOL preservation.

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

NCT04494425Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/24/2020

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT03734029Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/27/2018

Digital Support App Launches in UK to Address Rising Youth Cancer Cases

  • Cancer rates among people under 24 have surged 22% since early 2000s, prompting the Ella Dawson Foundation and Careology to launch a specialized digital support app for young cancer patients.
  • The app offers comprehensive features including symptom monitoring, medication tracking, and wellbeing support, with content from leading organizations like Macmillan Cancer Support and Cancer Research UK.
  • Initially rolling out at London's Royal Marsden Hospital, the platform addresses the unique challenges faced by young cancer patients while enabling clinicians to monitor patient progress remotely.

Anlotinib and Penpulimab Combination Shows Promise in First-Line HCC Treatment

• The Phase III APOLLO trial evaluated anlotinib plus penpulimab versus sorafenib in advanced hepatocellular carcinoma (aHCC). • The combination therapy significantly improved progression-free survival (PFS) to 6.9 months compared to 2.8 months with sorafenib. • Overall survival (OS) also saw improvement in the anlotinib plus penpulimab arm, with 16.5 months versus 13.2 months for sorafenib. • The safety profile of the combination was manageable, exhibiting fewer treatment-related adverse events than sorafenib.

Advancements in Penile Cancer Treatment: ESMO 2024 Highlights Neoadjuvant Strategies and Immunotherapy

  • ESMO 2024 highlighted the role of neoadjuvant chemotherapy for locally advanced penile squamous cell carcinoma, particularly in patients with bulky or bilateral inguinal nodes.
  • The InPACT ECOG-EA8134 trial is evaluating neoadjuvant therapy, including chemotherapy and chemoradiation, for cN1-3 squamous cell carcinoma of the penis, aiming for 400 patients.
  • HERCULES trial results showed a 39% overall response rate with pembrolizumab plus platinum-based chemotherapy in advanced penile squamous cell carcinoma, with enriched responses in TMB-high and HPV+ tumors.
  • Ongoing research emphasizes the importance of considering penile squamous cell carcinoma as distinct biological entities, guiding the development of next-generation immune checkpoint inhibitor-based trials.

WHO Approves Mpox Vaccine for Adults in Africa, Suggests Off-Label Use for Children Despite Limited Data

  • The WHO has prequalified Bavarian Nordic's MVA-BN vaccine for mpox, the first such approval, to aid procurement by international agencies.
  • While approved for adults, the WHO suggests the vaccine can be used off-label in children and pregnant women during outbreaks, despite limited clinical trial data in these groups.
  • Experts raise concerns about the safety profile in adults and the lack of efficacy and safety data in pediatric populations, urging caution.
  • Critics highlight the focus on mpox vaccination over more pressing public health issues in Africa, like malaria and malnutrition.

DLL3-Targeted Therapies Show Promise in Neuroendocrine Prostate Cancer

  • Delta-like ligand 3 (DLL3) is emerging as a potential therapeutic target for aggressive neuroendocrine prostate cancer, which often develops resistance to standard treatments.
  • Early clinical trials of DLL3-targeted T cell engagers, such as MK-6070, have demonstrated promising anti-tumor activity in patients with relapsed or refractory neuroendocrine prostate cancer.
  • PET imaging with 89Zr-SC16 may help in detecting and quantifying DLL3 expression in tumors, potentially improving patient selection for DLL3-targeted therapies.
  • While tarlatamab showed limited efficacy in a broad neuroendocrine prostate cancer cohort, ongoing research focuses on refining patient selection and exploring combination strategies to enhance treatment outcomes.

ctDNA Analysis Predicts Survival and Treatment Response in Colorectal Cancer

  • ctDNA positivity post-surgery strongly predicts recurrence and poorer overall survival in CRC patients, outperforming traditional risk factors.
  • ctDNA monitoring identifies patients who benefit from adjuvant chemotherapy (ACT), with MRD-positive patients showing significant improvement.
  • Clearance of ctDNA during ACT correlates with superior DFS and OS, while transient clearance indicates a high risk of recurrence.
  • Molecular recurrence detected by ctDNA precedes radiological recurrence, highlighting its potential for early intervention.

FDA Challenges AbbVie's Serena Williams Ubrelvy Ad for Misleading Migraine Claims

• FDA issues warning to AbbVie regarding misleading advertisements featuring Serena Williams for migraine drug Ubrelvy, citing unsubstantiated claims about pain elimination.
• The controversial advertisement suggests immediate pain relief after a single dose, which the FDA states has not been clinically demonstrated and could mislead healthcare providers and patients.
• This marks AbbVie's second FDA advertising violation for Ubrelvy, following a similar warning to Allergan in 2020, despite the drug generating over $1.2 billion in sales last year alongside Qulipta.

CheckMate 067: Nivolumab Plus Ipilimumab Shows Sustained Survival Benefit in Advanced Melanoma at 10 Years

  • The CheckMate 067 trial's 10-year data demonstrates a significant overall survival (OS) benefit for nivolumab plus ipilimumab in advanced melanoma compared to ipilimumab alone.
  • Median OS reached 71.9 months with the combination therapy versus 19.9 months with ipilimumab, marking the longest median OS in a phase 3 study of an anti-PD-1 agent.
  • Ten-year OS rates were 43% for nivolumab/ipilimumab, 37% for nivolumab monotherapy, and 19% for ipilimumab monotherapy, highlighting the potential for long-term remission.
  • Progression-free survival at 3 years is a strong surrogate marker for long-term survival, with 10-year melanoma-specific survival rates exceeding 96% in nivolumab-containing arms.

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

NCT01844505CompletedPhase 3
Bristol-Myers Squibb
Posted 6/11/2013

Sintilimab, Anlotinib, and Chemotherapy Show Promise in Treating Relapsed SCLC

  • A combination of sintilimab, anlotinib, and chemotherapy demonstrated a confirmed objective response rate of 60% in patients with relapsed small cell lung cancer (SCLC).
  • The median progression-free survival (PFS) was 6.0 months, and the median overall survival (OS) was 13.4 months, indicating a potential survival benefit.
  • ctDNA analysis revealed that KMT2D mutations may be associated with treatment resistance and poorer outcomes in SCLC patients.
  • The combination therapy was generally well-tolerated, with the most common treatment-related adverse events being leukopenia, anemia, and elevated GGT.

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