Pemetrexed

Novocure's Optune Lua Receives CE Mark for Metastatic Non-Small Cell Lung Cancer Treatment

a month ago

• Novocure's Optune Lua device has received CE Mark approval for treating metastatic non-small cell lung cancer (NSCLC) when used concurrently with immune checkpoint inhibitors or docetaxel in patients who have progressed on platinum-based therapy. • The Phase 3 LUNAR trial demonstrated a significant 3.3-month extension in median overall survival, with patients receiving Optune Lua plus an immune checkpoint inhibitor showing a remarkable 7.7-month survival benefit compared to immune checkpoint inhibitor alone. • Optune Lua delivers Tumor Treating Fields (TTFields) through wearable arrays, using electric fields to physically disrupt dividing cancer cells without significant systemic toxicity, representing the first substantial survival improvement for this patient population in over eight years.

Robust Pipeline for Nasopharyngeal Cancer Treatment Emerges with 25+ Pharmaceutical Companies Developing Novel Therapies

3 months ago

• A comprehensive pipeline analysis reveals over 25 pharmaceutical companies actively developing approximately 30 drug candidates for nasopharyngeal cancer, signaling significant industry investment in this therapeutic area. • BL-B01D1, a first-in-class bispecific antibody-drug conjugate targeting both EGFR and HER3, has advanced to Phase III clinical trials, showing promise for patients with recurrent or metastatic nasopharyngeal carcinoma. • Novel approaches in development include Takeda's TAK-500, a STING agonist immunostimulatory antibody drug conjugate, and Ascentage Pharma's APG-5918, highlighting diverse therapeutic strategies targeting this challenging cancer.

Merck Halts Final Phase 3 Keytruda Trial in Prostate Cancer After Failed Interim Analysis

3 months ago

• Merck discontinues KEYNOTE-641 trial evaluating Keytruda plus Xtandi in metastatic castration-resistant prostate cancer after showing no survival benefit at interim analysis. • The failure marks Merck's fourth unsuccessful late-stage trial of Keytruda in prostate cancer, highlighting the challenges of immunotherapy in this typically "cold" tumor type. • The company simultaneously reported an unexpected setback in KEYNOTE-789 studying Keytruda combination therapy in EGFR-mutated non-small cell lung cancer.

Keytruda Approved in China for Early-Stage NSCLC Treatment

5 months ago

• Keytruda gains approval in China for resectable stage II, IIIA, or IIIB NSCLC in combination with platinum-containing chemotherapy. • The approval is based on the KEYNOTE-671 trial, demonstrating a significant improvement in overall survival and event-free survival. • This marks Keytruda's fourth indication for NSCLC in China, extending its use to earlier stages of the disease. • The treatment involves neoadjuvant Keytruda plus chemotherapy, followed by adjuvant Keytruda monotherapy post-surgery.

HER2-Directed ADCs Expand Treatment Spectrum Across Solid Tumors

8 months ago

• Trastuzumab deruxtecan (T-DXd) shows promise across breast, gynecologic, gastrointestinal, lung, and genitourinary cancers, targeting HER2-positive, -mutated, and -amplified diseases. • In gynecologic cancers, the DESTINY-PanTumor02 trial demonstrated significant response rates with T-DXd in endometrial, cervical, and ovarian cancers, particularly in HER2 IHC3+ patients. • T-DXd has received FDA approval for HER2-mutant NSCLC and HER2-positive solid tumors, marking advancements in targeted therapies for previously hard-to-treat cancers. • Clinical trials like DESTINY-Breast03 and DESTINY-Gastric01 support T-DXd's efficacy, showing improved PFS and OS compared to standard treatments in breast and gastric cancers.

FDA Approves Keytruda for First-Line Treatment of Malignant Pleural Mesothelioma

8 months ago

• The FDA has approved Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy as a first-line treatment for unresectable advanced or metastatic malignant pleural mesothelioma. • The approval was based on the Phase 2/3 KEYNOTE-483 trial, which demonstrated a statistically significant improvement in overall survival compared to chemotherapy alone. • Patients receiving Keytruda plus chemotherapy had a median overall survival of 17.3 months, compared to 16.1 months for those receiving chemotherapy alone, reducing the risk of death by 21%. • The Keytruda regimen also showed significant improvements in progression-free survival and overall response rate, offering a new treatment option for this aggressive cancer.

Elraglusib Receives FDA Orphan Drug Designation for Soft Tissue Sarcoma

8 months ago

• Actuate Therapeutics' elraglusib, a novel GSK-3β inhibitor, has been granted Orphan Drug Designation by the FDA for soft tissue sarcoma (STS). • The FDA's decision underscores elraglusib's potential to address the unmet medical needs of patients with advanced cancers, including STS. • Elraglusib has demonstrated a favorable safety profile and antitumor activity across several solid tumors, including melanoma and pancreatic cancer. • A phase 2 trial is underway evaluating elraglusib in combination with gemcitabine and docetaxel for advanced sarcomas.

FDA Approves PEMFEXY® Combination Therapy for Metastatic Non-Small Cell Lung Cancer

2 years ago

• Eagle Pharmaceuticals' PEMFEXY® gains FDA approval for use with pembrolizumab and platinum chemotherapy in metastatic non-squamous NSCLC patients without EGFR or ALK aberrations. • PEMFEXY®, a ready-to-dilute liquid formulation, now holds the same indications as ALIMTA®, offering advantages like eliminating reconstitution steps. • This marks the fifth indication for PEMFEXY®, expanding its role in treating non-squamous NSCLC and mesothelioma, enhancing Eagle's oncology portfolio. • The approval strengthens Eagle Pharmaceuticals' position in the market, providing a valuable treatment option for patients undergoing chemotherapy.

Drug Development Updates