Amtagvi Prompts Responses in Non–Small Cell Lung Cancer

Among patients with previously treated non-squamous non-small cell lung cancer without actionable genetic mutations, new data has been released from the phase 2 IOV-LUN-202 clinical trial of Amtagvi (lifileucel) monotherapy.

The interim data was revealed in a news release issued by Iovance Biotherapeutics, the commercial biotechnology company working in novel polyclonal tumor infiltrating lymphocyte (TIL) therapies that is behind Amtagvi.

After a one-time treatment with Amtagvi monotherapy, the objective response rate (ORR) was 25.6%, with the news release noting that an objective response was observed in 10 out of 39 patients, including two complete responses, seven partial responses and one unconfirmed partial response. There was a disease control rate of 71.8%, and the median duration of response was not reached after a median follow-up of 25.4 months.

The company stated that it will present additional data from the trial at a medical meeting in 2026, with the trial expected to progress in 2026 towards a supplemental biologics license application for Amtagvi in non-squamous non-small cell lung cancer and a potential launch in the second half of 2027.

The U.S. Food and Drug Administration (FDA) previously approved Amtagvi for patients with advanced melanoma whose disease progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy in February 2024.

“It is exciting to see such an impressive response rate and durability observed in previously treated patients with NSCLC, because today there are only very limited treatment options, none of which demonstrate this quality of response and durability,” said Dr. Martin Wermke, Professor for Experimental Cancer Therapy and Director at the National Center for Tumor Diseases Dresden. “One-time treatment with [Amtagvi] monotherapy has the potential to benefit many patients with advanced NSCLC following initial treatment with an immune checkpoint inhibitor.”

Amtagvi, as explained by the National Cancer Institute on its website, is a treatment made of tumor-infiltrating lymphocytes, which are a type of immune cell that can recognize and kill tumor cells, from a patient’s tumor. These lymphocytes are tested in a laboratory in order to determine which ones best recognize tumor cells. The selected lymphocytes are then grown in large numbers in a laboratory and then given back to the patient to help their own immune system kill tumor cells.

The company noted in the news release that after initial treatment with immune checkpoint inhibitors and chemotherapy, patients with advanced non-small cell luyng cancer have limited treatment options, often receiving chemotherapy with limited durability — with standard-of-care docetaxel monotherapy showing an ORR of 12.8% with no complete responses, a median duration of response of 5.6 months and overall survival of 12.3 months.

“[Amtagvi] has demonstrated a potentially best-in-class clinical profile in previously treated advanced non-squamous NSCLC. The duration of response is unprecedented and is combined with an impressive response rate in a one-time monotherapy for a difficult-to-treat patient population,” stated Dr. Friedrich Graf Finckenstein, Chief Medical Officer of Iovance. “We will pursue regulatory approvals for [Amtagvi] monotherapy to effectively address the tens of thousands of patients with previously treated non-squamous advanced NSCLC.”

More About Amtagvi

Dr. Sunandana Chandra, associate professor of medicine at Northwestern University Feinberg School of Medicine in Chicago, said in an interview with CURE that Amtagvi has benefits and risks associated with it.

“The upside with TIL therapy is that it’s this novel, first-in-its-class approval [for] metastatic melanoma, where we’re using the patient’s own immune cells against the cancer,” she says. “The downside of TIL therapy is that it’s a rigorous regimen. It requires a huge commitment from the patient. It is only able to be given in a very limited number of sites across the country.”

References

1. “FDA Approves Amtagvi for Pretreated, Advanced Melanoma,” CURE; https://www.curetoday.com/view/fda-approves-amtagvi-for-pretreated-advanced-melanoma
2. “Amtagvi,” National Cancer Institute;
3. “Empwering the Immune System,” CURE; https://www.curetoday.com/view/empowering-the-immune-system

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