Iovance Biotherapeutics, Inc. (IOVA Quick QuoteIOVA - Free Report) announced that the first patient has been recently randomized in its phase III TILVANCE-301 study comparing Iovance’s lifileucel in combination with Merck’s (MRK Quick QuoteMRK - Free Report) Keytruda (pembrolizumab), against Keytruda monotherapy, in frontline patients with advanced (unresectable or metastatic) melanoma.

Iovance’s advanced melanoma treatment candidate, lifileucel is a novel therapy based on the company’s proprietary tumor infiltrating lymphocyte technology.

Keytruda, an anti-PD-1 therapy, is Merck’s blockbuster oncology drug and approved for several types of cancer, accounting alone for around 40% of Merck’s pharmaceutical sales. Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States.

Year to date, shares of IOVA have gained 35.2% against the industry’s 7.1% decline.

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The phase III TILVANCE-301 study is being conducted in two arms, seeking to randomize approximately 670 patients. The investigational late-stage study will evaluate the safety and efficacy of lifileucel in combination with pembrolizumab (experimental arm) compared with pembrolizumab monotherapy (control arm). The study is currently enrolling patients with advanced melanoma who have not received prior therapy for advanced disease. The dual primary endpoints of the TILVANCE-301 study are objective response rate (ORR) and progression-free survival (PFS).

We would like to remind the investors that in May 2023, the FDA accepted Iovance’s biologics license application, under priority review, for lifileucel to treat patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy. A decision from the regulatory body is expected on Nov 25, 2023.

Per a previous agreement with the FDA, the dual primary endpoints of ORR and PFS in the TILVANCE-301 can support accelerated and full approvals of lifileucel in frontline advanced melanoma. Also, it is expected that the TILVANCE-301 study will be well underway at the time of potential accelerated approval of lifileucel in post-anti-PD-1 melanoma. In this regard, the FDA has additionally agreed that the TILVANCE-301 study can simultaneously serve as the confirmatory trial for full approval in the initial indication of post-anti-PD-1 melanoma.

Iovance Biotherapeutics, Inc. Price and Consensus

Iovance Biotherapeutics, Inc. price-consensus-chart | Iovance Biotherapeutics, Inc. Quote

Zacks Rank and Stocks to Consider

Iovance currently has a Zacks Rank #3 (Hold).

A couple of better-ranked stocks in the biotech sector are Adaptimmune Therapeutics and Akero Therapeutics (AKRO Quick QuoteAKRO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has narrowed from 63 cents to 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 59 cents to 56 cents. Year to date, shares of ADAP have fallen by 30.9%.

ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.

In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.22 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.44 to $3.27. Year to date, shares of AKRO have gained by 0.7%.

AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.