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SAN CARLOS, Calif. - Iovance Biotherapeutics (NASDAQ:IOVA) reported Monday that its experimental tumor infiltrating lymphocyte (TIL) therapy lifileucel showed a 25.6% objective response rate in previously treated advanced nonsquamous non-small cell lung cancer (NSCLC) patients without actionable genetic mutations. The clinical-stage biotech company, currently valued at approximately $713 million, has seen its stock decline over 82% in the past year according to InvestingPro data.
The interim data from the registrational Phase 2 IOV-LUN-202 trial revealed that 10 of 39 patients responded to the one-time treatment, including two complete responses and eight partial responses. The disease control rate reached 71.8%, according to the company.
After a median follow-up of 25.4 months, the median duration of response has not yet been reached, suggesting durable benefits for responding patients.
The company indicated that the trial design aligns with FDA guidance for single-arm trials supporting accelerated approvals in areas of unmet medical need. Iovance expects to progress toward a supplemental Biologics License Application in 2026, with a potential launch in the second half of 2027.
"The safety profile for the lifileucel treatment regimen was consistent with the underlying disease, non-myeloablative lymphodepletion, and interleukin-2," the company stated. Improvements in safety were observed following the introduction of an updated regimen with reduced lymphodepletion.
Iovance noted that current standard treatment with docetaxel monotherapy in similar patient populations has shown a 12.8% response rate with a median duration of response of 5.6 months.
The company plans to present additional data from the trial at a medical meeting in 2026.
Iovance's Amtagvi became the first FDA-approved T cell therapy for a solid tumor earlier this year. The information in this article is based on a company press release.
In other recent news, Iovance Biotherapeutics reported its financial results for the second quarter of 2025, revealing a shortfall in revenue expectations. The company achieved $60 million in revenue, which was below the anticipated $67.1 million, resulting in a 10.58% negative surprise. Additionally, the earnings per share (EPS) were reported at -$0.33, missing the forecasted -$0.28. On the regulatory front, Health Canada granted conditional approval for Iovance's Amtagvi therapy for advanced melanoma patients who have no other treatment options. This approval allows Amtagvi to be used in adult patients with unresectable or metastatic melanoma that has progressed after prior therapies. Furthermore, H.C. Wainwright has reiterated its Buy rating on Iovance Biotherapeutics, maintaining a $20.00 price target following the Canadian approval. These developments highlight both the challenges and opportunities facing Iovance Biotherapeutics in the evolving landscape of cancer treatment.
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