Eortc | MedPath

Immunocore Reports Strong KIMMTRAK Sales Growth and Advances Clinical Pipeline in 2024

3 months ago

• KIMMTRAK achieved $310 million in net sales for 2024, with $84.1 million in Q4, marking 11 consecutive quarters of growth and launches in 14 new territories. • The company advanced its PRAME portfolio with first patient randomization in Phase 3 PRISM-MEL-301 trial and continued enrollment in combination studies for ovarian cancer and NSCLC. • Immunocore maintained strong financial position with $820.4 million in cash and marketable securities, while progressing autoimmune and infectious disease programs.

HyBryte Shows Sustained Improvement in CTCL Lesions Post-Treatment

6 months ago

• Soligenix's HyBryte demonstrated continued improvement in cutaneous T-cell lymphoma (CTCL) lesions even after treatment cessation. • A comparative study showed a statistically significant improvement in plaque lesion response with HyBryte versus Valchlor at week 16 (p=0.006). • HyBryte was well-tolerated, with no related adverse events, contrasting with Valchlor, which had a 60% related adverse event rate. • Soligenix plans to initiate a confirmatory Phase 3 trial (FLASH2) to further evaluate HyBryte's efficacy and safety in CTCL patients.

Niraparib Shows Promise in Extending Progression-Free Survival in Epithelial Ovarian Cancer

6 months ago

• Niraparib monotherapy extends real-world progression-free survival (rwPFS) and time to next treatment (rwTTNT) in patients with epithelial ovarian cancer (EOC). • Patients with homologous recombination-deficient (HRd) tumors, particularly those with BRCA-mutated tumors, experienced longer rwPFS and rwTTNT. • Niraparib demonstrates clinical benefit in stage III EOC patients with no visible residual disease (NVRD) after primary cytoreductive surgery (PCS). • Niraparib stands out among PARP inhibitors for its broad frontline maintenance therapy approval in EOC, regardless of BRCA mutation or HRD status.

Estimand Framework Enhances Analysis of Patient-Reported Outcomes in Lung Cancer Trials

6 months ago

• A recent study emphasizes the importance of the estimand framework in analyzing patient-reported outcomes (PROs) within single-arm trials, particularly in oncology. • The research illustrates various estimands for assessing global Quality of Life (QoL) in patients with ALK-positive non-small cell lung cancer. • Different strategies for handling intercurrent events like treatment discontinuation and death significantly impact the interpretation of PRO data. • The application of the estimand framework provides a more comprehensive and nuanced understanding of treatment effects on patient well-being.

Soligenix Forms European Medical Advisory Board for HyBryte CTCL Trial

6 months ago

• Soligenix has established a European Medical Advisory Board (MAB) to guide its Phase 3 trial of HyBryte™ for cutaneous T-cell lymphoma (CTCL). • The Phase 3 study will enroll approximately 80 patients in the U.S. and Europe, with topline results expected in the second half of 2026. • The MAB comprises European physicians experienced in CTCL treatment and clinical research, offering expertise in clinical strategies and regulatory interactions. • HyBryte™ (synthetic hypericin) is a photodynamic therapy being evaluated for early-stage CTCL, with potential for improved safety over existing treatments.

VIGex and ctDNA Analysis Improves Immunotherapy Response Prediction in Solid Tumors

6 months ago

• A recent study in *JCO Precision Oncology* shows that combining the VIGex gene expression signature with circulating tumor DNA (ctDNA) analysis may enhance immunotherapy response prediction. • The VIGex signature classifies the tumor microenvironment's inflammatory status, with the VIGex-Hot subgroup showing better survival rates in patients treated with pembrolizumab. • Combining VIGex classification with ctDNA dynamics improves the prediction of response to immunotherapy, indicating greater clinical benefit in VIGex-Hot tumors with decreased ctDNA levels. • A phase III clinical trial is planned to prospectively validate the clinical utility of VIGex and ctDNA dynamics for patient selection and treatment strategies.

Adjuvant Nivolumab Demonstrates Highest Cure Rate in Resected Melanoma

7 months ago

• Analysis of CheckMate 238 and EORTC 18071 trials reveals estimated cure rates with adjuvant nivolumab, ipilimumab, and placebo in resected stage III/IV melanoma. • Nivolumab showed the highest estimated cure rate at 48.3%, compared to 38.2% with ipilimumab in CheckMate 238, after a minimum follow-up of 5 years. • In EORTC 18071, ipilimumab showed a cure rate of 38.0% compared to 29.2% with placebo, with a median follow-up of 6.9 years. • Indirect comparison showed significantly higher likelihood of cure with nivolumab vs placebo (OR = 2.33) and ipilimumab vs placebo (OR = 1.55).

MAIA Biotechnology Presents Promising Preclinical Data on Novel THIO Prodrugs

7 months ago

• MAIA Biotechnology will present preclinical results of its second-generation THIO prodrugs, MAIA-2021-20 and MAIA-2022-12, at the ENA 2024 Symposium. • The THIO-based prodrugs demonstrated high efficacy in preclinical studies, overcoming immunotherapy resistance in advanced tumors. • Studies showed tumor growth inhibition in models of lung cancer, colorectal carcinoma, melanoma, and hepatocellular carcinoma. • MAIA is actively working to advance these novel telomere-targeting agents toward clinical development.

HyBryte™ Shows Improved Response Rates in Cutaneous T-Cell Lymphoma with Extended Treatment

8 months ago

• Soligenix's HyBryte™ (synthetic hypericin) demonstrates improved response rates in cutaneous T-cell lymphoma (CTCL) with extended treatment and increased light doses. • Presentations at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting highlight the utility of longer treatment times with HyBryte™. • Studies show HyBryte™ has minimal systemic exposure and is relatively efficacious and tolerable compared to Valchlor® in CTCL treatment. • A second Phase 3 trial, FLASH2, is expected to begin before the end of 2024, building on positive results from the initial FLASH study.

KEYTRUDA Plus Chemoradiotherapy Improves Overall Survival in High-Risk Cervical Cancer

8 months ago

• KEYNOTE-A18 trial shows KEYTRUDA (pembrolizumab) plus chemoradiotherapy significantly improves overall survival in high-risk, locally advanced cervical cancer patients. • The KEYTRUDA regimen reduced the risk of death by 33% compared to chemoradiotherapy alone, establishing a potential new standard of care. • The 36-month overall survival rate was 82.6% with KEYTRUDA plus chemoradiotherapy versus 74.8% with chemoradiotherapy alone. • The safety profile of KEYTRUDA in combination with chemoradiotherapy was consistent with previous studies, with no new safety signals identified.

EORTC and Medidata Extend Partnership to Enhance Oncology Clinical Trials

8 months ago

• The European Organisation for Research and Treatment of Cancer (EORTC) has extended its partnership with Medidata for four years. • The collaboration aims to improve patient access to oncology clinical trials and accelerate the delivery of new treatments. • EORTC is leveraging 13 Medidata solutions to streamline data management and enhance patient engagement in clinical trials. • The partnership will explore joint research and data collaboration with Medidata AI to improve cancer care standards.

Radionuclide Therapy Shows Promise in Advanced Prostate Cancer Treatment

2 years ago

• Radionuclide therapies are emerging as promising options for treating metastatic castration-resistant prostate cancer (mCRPC), especially after resistance to standard treatments. • Lutetium-177 PSMA-617 (Lu-PSMA-617) has demonstrated overall survival benefits in mCRPC patients, leading to FDA and EMA approvals for PSMA-positive cases. • Ongoing clinical trials are exploring Lu-PSMA-617 in earlier stages of prostate cancer and in combination with other therapies like androgen deprivation and immunotherapy. • Targeted alpha therapy using Actinium-225 labeled PSMA ligands shows potential for improved outcomes, particularly in patients who do not respond to Lutetium-177 based treatments.

The Reporting of Adverse Events in Oncology Phase III Trials

9 years ago

A study comparing the current status of adverse events (AEs) reporting in oncology phase III trials with the expectations of the European Organization for Research and Treatment of Cancer (EORTC) membership reveals significant discrepancies. While most reports include grade 3/4 AEs, there's a lack of comprehensive reporting on grade 5 AEs, AEs leading to study withdrawal, and dose reduction, contrary to EORTC members' expectations.