Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) has announced its third quarter and year-to-date 2024 financial results, highlighting strong commercial progress with Amtagvi™ (lifileucel), the first FDA-approved T cell therapy for a solid tumor. The company is focused on expanding its commercial footprint and advancing its pipeline of tumor-infiltrating lymphocyte (TIL) therapies.
Amtagvi's Strong Commercial Launch
Iovance reported total product revenue of $58.6 million for the third quarter of 2024, which includes $42.1 million from Amtagvi sales in the U.S. and $16.5 million from Proleukin® sales. Since the commercial launch of Amtagvi in April 2024, 146 patients have been infused with the therapy. The company reaffirmed its revenue guidance of $160 to $165 million for FY24 and $450 to $475 million for FY25, driven by increasing demand and broader utilization of Amtagvi.
"Iovance is executing a successful U.S. commercial launch of Amtagvi™ for patients with previously treated advanced melanoma," said Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance. "Robust demand for Amtagvi and Proleukin® continues to grow as our expanding network of authorized treatment centers (ATCs) and outreach to community oncologists broaden the utilization of Amtagvi, driving a higher volume of patient referrals."
Expansion into New Markets
Iovance is actively pursuing regulatory approvals to expand its commercial footprint beyond the U.S. Marketing authorization applications (MAAs) have been validated and accepted for review by European regulatory authorities, with potential approval in the UK expected in the first half of 2025, followed by the EU and Canada in the second half of 2025. These submissions target the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Advancing the TIL Cell Therapy Pipeline
Iovance is also making significant progress with its TIL cell therapy pipeline. Enrollment is accelerating in the IOV-LUN-202 registrational Phase 2 trial in post-anti-PD-1 non-small cell lung cancer (NSCLC). The FDA has provided positive regulatory feedback on the proposed potency matrix for lifileucel in NSCLC, and Iovance expects data from the IOV-LUN-202 trial to support a potential accelerated U.S. approval for lifileucel in NSCLC in 2027.
Updated preliminary results from Cohort 3A in the IOV-COM-202 trial continue to demonstrate robust response rates and durability for lifileucel in combination with pembrolizumab in NSCLC patients who were not previously treated with immune checkpoint inhibitor therapy. A confirmed objective response was observed in 9 of 14 EGFR wild type patients (64.3%), including 6 of 11 (54.5%) patients who also had difficult-to-treat PD-L1 negative disease. Median duration of response (DOR) was not reached at a median study follow up of 26.5 months.
Patient enrollment has commenced in the IOV-END-201 Phase 2 trial to investigate lifileucel for advanced endometrial cancer patients who have progressed after platinum-based chemotherapy and anti-PD-1 therapy regardless of mismatch repair (MMR) status.
Financial Position and Manufacturing Expansion
As of September 30, 2024, Iovance had cash, cash equivalents, investments, and restricted cash of $403.8 million. The company expects this, along with anticipated product revenue, to be sufficient to fund current and planned operations, including manufacturing expansion, into early 2026. Iovance is expanding its manufacturing capacity at the Iovance Cell Therapy Center (_i_CTC) to supply TIL cell therapies to more than 5,000 patients annually in the next few years.
Iovance currently owns more than 230 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies that are expected to provide Amtagvi with exclusivity through at least 2042.
