Lifileucel

Selected TIL Therapy Combined with Pembrolizumab Shows Promising Results for Metastatic Gastrointestinal Cancers

2 months ago

• NIH researchers report that a new form of tumor infiltrating lymphocyte (TIL) therapy combined with pembrolizumab achieved 23.5% objective response rate in patients with metastatic gastrointestinal cancers, compared to 7.7% with selected TILs alone. • The clinical trial included 91 heavily pretreated patients with various gastrointestinal cancers, demonstrating efficacy across multiple tumor types including colon, rectal, pancreatic, and bile duct cancers. • Response durations ranged from 4 months to 3.5 years in the combination therapy group, offering new hope for extending cell-based immunotherapies to common solid tumors that have historically been resistant to such approaches.

Iovance Biotherapeutics Continues Expansion with Nearly 300 New Stock Option Grants to Support TIL Therapy Development

2 months ago

• Iovance Biotherapeutics granted inducement stock options covering 297,600 shares to fifty new employees on April 17, 2025, following similar grants of 308,710 shares to forty-three employees in March. • The company is expanding its workforce to support the commercialization of Amtagvi, the first FDA-approved T-cell therapy for a solid tumor indication, and further development of its tumor infiltrating lymphocyte (TIL) platform. • Each stock option has a three-year vesting period with an exercise price of $3.06 per share, reflecting Iovance's strategic investment in human capital to advance its cancer immunotherapy pipeline.

FDA Approves ORLYNVAH™: First New Oral Treatment for Uncomplicated UTIs in 25 Years

3 months ago

• Iterum Therapeutics receives FDA approval for ORLYNVAH™, marking the first branded uncomplicated UTI treatment to enter the U.S. market in over 25 years and the first oral penem antibiotic approved in the country. • The drug demonstrates significant potential against multi-drug resistant pathogens, specifically targeting Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women with limited treatment options. • Iterum reports $24.1 million in cash reserves as of December 2024, with funding projected to sustain operations into the second half of 2025 while pursuing pre-commercialization activities.

Iovance Biotherapeutics Advances Melanoma Treatment Portfolio with Amtagvi Launch and Pipeline Expansion

4 months ago

Iovance Biotherapeutics reports encouraging initial sales of $58.6 million for Amtagvi in Q3, while advancing its TIL therapy pipeline. The company is expanding its clinical programs into frontline melanoma and lung cancer, alongside development of next-generation TIL therapy IOV-4001, despite facing manufacturing cost challenges.

TIL Therapy and Novel Combinations Advance Melanoma Treatment

5 months ago

• Lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, received FDA accelerated approval for unresectable or metastatic melanoma after PD-1 inhibitor treatment. • Studies show lifileucel, alone or with pembrolizumab, yields objective response rates of 31.5% to 65.2% in advanced melanoma, even after multiple prior therapies. • IBI363, a PD-1, IL-2α bispecific antibody, demonstrates promising disease control and objective response rates in melanoma patients who have progressed on PD-1 inhibitors. • Personalized cancer vaccine mRNA-4157 (V940) combined with pembrolizumab significantly reduces the risk of disease recurrence in resected stage IIIB to IV melanoma.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.