Iovance Biotherapeutics Releases Positive Clinical Data for Lifileucel in Advanced Melanoma


Analysis included a 29% objective response rate in cohort 4 of the C-144-01 study, the company says.

Iovance Biotherapeutics announced clinical results from its C-144-01 clinical study in individuals with advanced, either metastatic or unresectable, melanoma who progressed on prior anti-PD-1/L1 therapy, and if BRAF-mutation positive, also on prior BRAF or BRAD.MEK inhibitor therapy.

“Treatment of melanoma patients after failure of anti-PD-1 therapy remains a critical unmet medical need without an approved therapeutic option. Available care for metastatic melanoma patients in this setting is chemotherapy, which has been reported to offer a 4% to 10% response rate with a very short median duration of response,” Friedrich Graf Finckenstein, MD, chief medical officer of Iovance, said in a statement.

We are excited about the results from registrational Cohort 4 of the C-144-01 study and the potential of lifileucel as a new treatment option for these patients,”

In the registrational cohort 4, the objective response rate (ORR), by an independent review committee using RECIST 1.1 criteria, was 29% with 3 complete responses and 22 partial responses.

The median duration (DOR) of response in cohort 4 was 10.4 months, with a median study follow-up of 23.5 months. The data show that the 1-time treatment with lifileucel therapy may provide meaningful benefit in heavily pre-treated individuals.

Additionally, cohort 4’s findings were supported by cohort 2’s, which showed that the ORR was 35%, with 5 complete responses and 18 partial responses. The median DOR in cohort 2 was not reached, with a median study follow-up of 36.6 months.

Further, the ORR for pooled individuals in both cohorts was 31%, while a median DOR was not reached at a median study follow up of 27.6 months.

Individuals in cohort 4 had a higher baseline disease burden than those in cohort 2, which included a substantially higher proportion of individuals with elevated baseline lactate dehydrogenase levels.

Additionally, individuals in cohort 2 also had approximately half the cumulative duration of anti-PD-1 therapy before lifileucel therapy by comparison with individuals in cohort 4. Reduced duration of prior anti-PD-1 therapy was shown to be associated with an increase of DOR to lifileucel.

The treatment-emergent adverse event (AEs) profile in both cohorts was consistent with the underlying disease and known AE profiles of non-myeloablative lymphodepletion and interleukin-2/. It was also consistent between both cohorts.

“We are pleased to report positive results for lifileucel from the registrational cohort 4 data from the C-144-01 study. Iovance is proceeding toward submission of a [biologic license application (BLA)] in August 2022 using these results, as well as the potentially supportive results from Cohort 2 of the C-144-01 study. We thank our patients, their families, and our investigators, employees, shareholders, and advocates for their support,” Frederick Vogt, PhD, JD, interim president and CEO of Iovance, said in the statement.

We look forward to reporting further progress with our lifileucel BLA and launch preparations in 2022,”

Iovance plans to present the additional data from both cohorts at a meeting in the second half of 2022. The planned BLA submission for lifileucel for advanced melanoma using these data remain on track for August 2022.


Iovance Biotherapeutics announces positive clinical data for lifileucel in advanced melanoma. Iovance Biotherapeutics. News release. May 26, 2022. Accessed June 1, 2022.

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