CytomX | MedPath

CytomX Doses First Patient in Combination Trial of CX-801 with Keytruda for Metastatic Melanoma

6 days ago

• CytomX Therapeutics has dosed the first patient in a Phase 1 trial combining its masked interferon alpha-2b (CX-801) with Merck's Keytruda in patients with metastatic melanoma. • The novel combination aims to address the high unmet need in PD-1 refractory melanoma by localizing interferon's potent immune-stimulating effects to tumors while minimizing systemic toxicities. • Initial Phase 1a translational and biomarker data from this study are expected in the second half of 2025, potentially advancing a new approach in combination immuno-oncology therapy.

CytomX's CX-2051 Shows Promising 28% Response Rate in Advanced Colorectal Cancer Phase 1 Trial

13 days ago

• CytomX's EpCAM-targeting antibody-drug conjugate CX-2051 demonstrated a 28% confirmed response rate in late-line colorectal cancer patients, significantly outperforming current standard therapies with single-digit response rates. • The novel PROBODY® masking technology appears to successfully target EpCAM, a previously "undruggable" tumor antigen, with manageable safety profile and no dose-limiting toxicities observed in the Phase 1 study. • Median progression-free survival reached 5.8 months with 43% response rate at the highest dose level (10 mg/kg), supporting plans to advance to Phase 2 trials in first half of 2026.

TG Therapeutics' Briumvi Exceeds Expectations, Eyes Subcutaneous Formulation and Azer-Cel Trial in MS

4 months ago

• TG Therapeutics announced that Briumvi's 2024 sales reached $310 million, surpassing initial expectations, driven by strong adoption in relapsing forms of multiple sclerosis (RMS). • The company anticipates $540 million in total global revenue for 2025, with $525 million expected from Briumvi sales, signaling continued growth and market penetration. • A pivotal program for a subcutaneous formulation of Briumvi is slated to begin in 2025, offering a more convenient administration route for RMS patients. • TG Therapeutics plans to initiate a Phase 1 trial for azer-cel in progressive MS, expanding its pipeline and addressing unmet needs in more advanced stages of the disease.

Sarclisa (Isatuximab) Shows Promise in Multiple Myeloma Treatment: China Approval and Subcutaneous Formulation Advances

5 months ago

• China's NMPA has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone for relapsed/refractory multiple myeloma, marking a significant milestone for Sanofi. • A Phase 3 IRAKLIA trial demonstrated that subcutaneous isatuximab, delivered via an on-body system, achieved non-inferior objective response rates compared to intravenous administration. • Regulatory submissions for subcutaneous isatuximab are planned in the US and EU in the first half of 2025, potentially offering a more convenient administration option for patients.

Corcept Therapeutics Submits New Drug Application for Relacorilant to Treat Cushing's Syndrome

5 months ago

• Corcept Therapeutics has submitted a New Drug Application to the FDA for relacorilant, a selective cortisol modulator designed to treat patients with endogenous hypercortisolism (Cushing's syndrome). • The application is supported by positive results from multiple clinical trials, including the pivotal GRACE trial, Phase 3 GRADIENT study, and long-term extension studies, demonstrating improvements in various symptoms with an acceptable safety profile. • Relacorilant showed no instances of serious adverse events common in current treatments, such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation, positioning it as a potential new standard of care.

Pancreatic Cancer: Advances in Treatment and Research Bring Hope in 2024

5 months ago

• The five-year relative survival rate for pancreatic cancer has risen to 13%, marking the third consecutive year of improvement, yet it remains the lowest among major solid tumors. • Four new drug approvals for pancreatic cancer occurred in 2024, including one first-line treatment and three targeted agents for previously treated advanced disease. • A Phase 3 clinical trial demonstrated an overall survival benefit using Tumor Treating Fields (TTFields) in combination with chemotherapy for unresectable, locally advanced pancreatic cancer. • Precision medicine is advancing with the FDA approval of Bizengri for NRG1 fusion-positive pancreatic cancer and the ongoing RASolute 302 trial evaluating RMC-6236, a RAS inhibitor.

Tolebrutinib Receives FDA Breakthrough Therapy Designation for Non-Relapsing Secondary Progressive Multiple Sclerosis

5 months ago

• The FDA has granted Breakthrough Therapy designation to tolebrutinib for adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). • The designation is based on positive results from the HERCULES phase 3 study, which demonstrated a 31% delay in disability progression compared to placebo. • Tolebrutinib is the first brain-penetrant BTK inhibitor to receive this designation for MS, addressing a critical unmet need in delaying disability progression. • Regulatory submissions for tolebrutinib are being finalized in the US and EU, with ongoing studies for primary progressive MS anticipated in H2 2025.