Iovance Biotherapeutics Q1 2024 Financial Results and Updates

Iovance Biotherapeutics, Inc., a leading biotechnology company, has reported remarkable progress in the first quarter of 2024, highlighted by the U.S. FDA approval and subsequent U.S. commercial launch of Amtagvi™ (Lifileucel) for treating advanced melanoma. This approval marks a significant milestone as Amtagvi becomes the first FDA-approved T-cell therapy specifically for a solid tumor indication.

Frederick Vogt, Interim President and CEO of Iovance, expressed his optimism about the company’s transformative growth, noting an immediate and growing demand for Amtagvi. Over 100 patients have already enrolled for the therapy across more than 40 authorized treatment centers (ATCs), and the company aims to authorize approximately 50 ATCs by the end of May 2024, with a goal to surpass 70 ATCs by the end of the year.

Iovance’s manufacturing capabilities have met initial expectations, with a turnaround time of about 34 days from receiving patient cells to shipping the final product back to ATCs. The U.S. launch of Amtagvi is expected to drive significant revenue, further bolstered by sales of Proleukin®, a component of the treatment regimen. Amtagvi has also been added as a preferred second-line or subsequent therapy in the National Comprehensive Cancer Network® guidelines for cutaneous melanoma.

Reimbursement processes have been successful, with over 75% of enrolled Amtagvi patients covered by private payers. This has set a solid precedent for reimbursement success, as payers covering more than 200 million lives have already authorized the treatment.

Looking forward, Iovance plans to expand Amtagvi into new markets and indications. The company remains on track to submit regulatory dossiers in the European Union by the second quarter of 2024 and in the United Kingdom and Canada by the second half of 2024. Further expansion into Australia and other countries is planned for 2025.

Iovance’s clinical pipeline is robust, with several promising developments. The Phase 3 TILVANCE-301 trial for lifileucel in combination with pembrolizumab in frontline advanced melanoma is progressing well, with strong momentum in patient enrollment globally. An oral presentation of updated clinical data will be featured at the American Society of Clinical Oncology (ASCO) Annual Meeting on May 31, 2024.

In the realm of non-small cell lung cancer (NSCLC), the IOV-LUN-202 Phase 2 trial resumed patient enrollment after the FDA lifted a partial clinical hold. The trial has garnered high demand, and regulatory feedback has been positive, with expectations for full enrollment by 2025.

A Phase 2 trial for lifileucel in advanced endometrial cancer is set to begin in the second quarter of 2024. This trial aims to address a significant unmet medical need in the post-anti-PD-1 treatment setting, particularly for patients who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy.

Iovance is also advancing its next-generation TIL pipeline. The IOV-4001 (PD-1 Inactivated TIL Cell Therapy) trial is moving into the Phase 2 efficacy stage, and an IND application for a Phase 1/2 trial of IOV-3001, a modified interleukin-2 fusion protein, is planned for the third quarter of 2024. Additionally, the company is developing a cytokine-tethered TIL therapy, IOV-5001, with plans to submit an IND in early 2025.

To support the growing demand for its therapies, Iovance is expanding its manufacturing capacity at the Iovance Cell Therapy Center (iCTC) to accommodate more than 5,000 patients annually in the coming years.

The company’s financial position remains strong, with $362.6 million in cash, cash equivalents, investments, and restricted cash as of March 31, 2024. This financial stability, along with anticipated revenue from Amtagvi and Proleukin, is expected to sustain operations well into the second half of 2025.

In summary, Iovance Biotherapeutics is poised for significant growth with the successful launch of Amtagvi, a strong pipeline of clinical trials, and strategic expansion into new markets. The company continues to lead in the development of innovative TIL therapies, aiming to transform cancer treatment and improve patient outcomes globally.