Iovance (IOVA) Focuses on Seeking Nod for Melanoma Therapy

Iovance Biotherapeutics IOVA has been progressing well with the clinical development of its tumor-infiltrating lymphocyte (TIL) candidates — lifileucel and LN-145.

Without any marketed products and revenue-generating collaborations, Iovance is highly dependent on its pipeline’s successful development and potential commercialization. These candidates target oncology indications, which represent significant potential.

The lead candidate in Iovance’s pipeline is lifileucel, which is being developed as a monotherapy for treating metastatic melanoma and metastatic cervical cancer in two mid-stage studies. The company started a rolling submission of the biologics license application (BLA), seeking approval for lifileucel in August 2022 for melanoma. The company is also developing combination therapies of lifileucel for other oncology indications.

This BLA is supported by data from the pivotal cohort 4 of the phase II C-144-01 study, announced in May 2022, which evaluated lifileucel in heavily pre-treated melanoma patients. Participants who were treated with the drug achieved an overall response rate (ORR) of 29%. This result was consistent with cohort 2 of the C-144-01 study, which achieved an ORR of 35%. Overall, data from both cohort 2 and cohort 4 showed that one-time treatment with lifileucel has the potential to provide meaningful benefits to heavily pre-treated patients.

The BLA is also supported by positive feedback from the FDA on the potency assays and assay matrix issues for lifileucel as a potential treatment of melanoma, which the company received on Apr 1, 2022.

The FDA’s feedback on potency assays and assay matrix was much needed for Iovance as management could not initiate regulatory filing for lifileucel in melanoma since the issue began in October 2020. As a result of this resolution, management can now proceed with plans for regulatory filings in other indications.

Iovance plans to start a phase III study later this year to evaluate the combination of lifileucel and Merck’s MRK blockbuster PD-1 inhibitor, Keytruda (pembrolizumab), as a potential treatment for immune checkpoint inhibitor naïve frontline metastatic melanoma. This late-stage study will be a confirmatory study for the pivotal Cohort 4 of the C-144-01 study.

The novel combination of lifileucel and Merck’s Keytruda demonstrated a safe clinical profile. Iovance has also conducted several studies evaluating this combination across multiple solid tumor indications. The clinical studies have shown encouraging results in patients compared to treatments with either lifileucel or MRK’s Keytruda as monotherapies in study participants.

Iovance is investigating LN-145 as a potential treatment for head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) in separate mid-stage studies.

Another ongoing phase II study, IOV-COM-202, which is composed of seven cohorts is evaluating Iovance’s TIL therapies in multiple settings and for several indications, both as a monotherapy and in combination with Merck’s Keytruda or Bristol-Myers’ BMY Opdivo/Yervoy.

Opdivo and Yervoy are two of the many blockbuster drugs marketed by Bristol Myers and are key drivers of its top line. In first-half 2022, Bristol Myers generated nearly $3.99 billion from Opdivo sales and recorded $1.04 billion as product revenues from Yervoy.

Iovance is also focused on expanding its pipeline beyond lifileucel and LN-145. Earlier this year, management announced that the FDA had accepted its regulatory filing to start clinical studies for its first TALEN-edited TIL therapy, IOV-4001. The company intends to start a phase I/II study later this year, evaluating this candidate in patients with advanced melanoma and metastatic NSCLC in two separate cohorts.

IOV-4001 utilizes the TALEN technology licensed from Cellectis CLLS. This license is part of a collaboration finalized between Iovance and CLLS in 2020. Per the agreement terms, IOVA has an exclusive worldwide license to use Cellectis’ proprietary TALEN technology to develop gene-editing TIL therapies targeting cancer. In return, Cellectis will be entitled to receive milestones and royalty payments from Iovance upon potential development and successful commercialization of the products developed using the TALEN technology.

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