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Iovance (IOVA) Starts Rolling BLA With FDA for Melanoma Therapy
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Iovance Biotherapeutics (IOVA - Free Report) initiated a rolling submission of the biologics license application (BLA) to the FDA seeking approval for its tumor infiltrating lymphocyte (TIL) therapy, lifileucel, in heavily pre-treated melanoma patients.
The BLA seeks FDA’s approval for lifileucel to treat patients with advanced unresectable or metastatic melanoma, which has progressed on or after prior anti-PD-1/L1 therapy. In case the melanoma is BRAF mutation-positive, it should have also been treated with prior BRAF or BRAF/MEK inhibitor therapy.
The BLA is supported by data from the pivotal Cohort 4 of the phase II C-144-01 study, which evaluated lifileucel in the above-mentioned patients. The study’s data, announced earlier in May, showed that participants who were administeredlifileucel achieved an overall response rate (ORR) of 29%, with three complete responses and 22 partial responses. While the median duration of response (DOR) in cohort 4 was 10.4 months, the median study follow-up was 23.5 months.
The company also reported data from cohort 2 of the study, which showed that the drug achieved an ORR of 35% with five complete responses and 18 partial responses. While the cohort 2 study did not achieve its median DOR, the median study follow-up was 36.6 months.
If the BLA is approved, lifileucel will be the first FDA-approved individualized, one-time cell therapy for melanoma patients. It willalso be Iovance’s first-ever therapy to receive FDA approval. An approval to lifileucel will help cater to the needs of melanoma patients, who have already been treated with standard-of-care medications and have limited treatment options.
Shares of Iovance have fallen 38.8% in the year-to-date period compared with the industry’s 21.6% decline.
Image Source: Zacks Investment Research
Unlike a full submission, a rolling submission allows a company to submit portions of the BLA on an ongoing basis. This benefits the company as the submissions can be reviewed by the FDA as early as possible. Iovance expects the rolling submission to be completed by fourth-quarter 2022.
Lifileucel was granted a regenerative medicine advanced therapy (RMAT) designation by the FDA for advanced melanoma indication in 2018. Therapies that are granted RMAT designation must be intended to treat serious or life-threatening conditions. If a candidate is designated as RMAT, it will enjoy all benefits of fast-track and breakthrough therapy designations.
Lifileucel is also being evaluated in other clinical studies. Iovance intends to start a phase III study later this year to evaluate lifileucel in combination with Merck’s (MRK - Free Report) blockbuster PD-1 inhibitor Keytruda (pembrolizumab). The late-stage study will evaluate the lifileucel-pembrolizumab combo as apotential treatment for immune checkpoint inhibitor naïve frontline metastatic melanoma. IOVA already evaluated this combination for the given indication in a cohort of the phase II study (IOV-COM-202). Data from the cohort demonstrated an overall response rate of 67%.
A multi-center study, IOV-COM-202 is composed of seven cohorts evaluating Iovance’s TIL therapies in multiple settings and for several indications, both as a monotherapy and in combination with Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.
A key revenue generator for Merck, Keytruda is approved for the treatment of many cancer indications, globally. During second-quarter 2022, MRK recorded $5.3 billion worth of sales from Keytruda. MRK is also evaluating Keytruda across a wide number of indications. The studies are progressing well.
Opdivo and Yervoy are two of the many blockbuster drugs marketed by Bristol Myers. Both drugs are key top-line drivers for BMY. In second-quarter 2022, Bristol Myers generated $2.1 billion from Opdivo sales and recorded $525 million as product revenues from Yervoy.
In the past 30 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.75. Loss estimates for 2023 have narrowed from $3.91 to $3.77 during the same period. Shares of Morphic have lost 33.9% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.
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Iovance (IOVA) Starts Rolling BLA With FDA for Melanoma Therapy
Iovance Biotherapeutics (IOVA - Free Report) initiated a rolling submission of the biologics license application (BLA) to the FDA seeking approval for its tumor infiltrating lymphocyte (TIL) therapy, lifileucel, in heavily pre-treated melanoma patients.
The BLA seeks FDA’s approval for lifileucel to treat patients with advanced unresectable or metastatic melanoma, which has progressed on or after prior anti-PD-1/L1 therapy. In case the melanoma is BRAF mutation-positive, it should have also been treated with prior BRAF or BRAF/MEK inhibitor therapy.
The BLA is supported by data from the pivotal Cohort 4 of the phase II C-144-01 study, which evaluated lifileucel in the above-mentioned patients. The study’s data, announced earlier in May, showed that participants who were administeredlifileucel achieved an overall response rate (ORR) of 29%, with three complete responses and 22 partial responses. While the median duration of response (DOR) in cohort 4 was 10.4 months, the median study follow-up was 23.5 months.
The company also reported data from cohort 2 of the study, which showed that the drug achieved an ORR of 35% with five complete responses and 18 partial responses. While the cohort 2 study did not achieve its median DOR, the median study follow-up was 36.6 months.
If the BLA is approved, lifileucel will be the first FDA-approved individualized, one-time cell therapy for melanoma patients. It willalso be Iovance’s first-ever therapy to receive FDA approval. An approval to lifileucel will help cater to the needs of melanoma patients, who have already been treated with standard-of-care medications and have limited treatment options.
Shares of Iovance have fallen 38.8% in the year-to-date period compared with the industry’s 21.6% decline.
Image Source: Zacks Investment Research
Unlike a full submission, a rolling submission allows a company to submit portions of the BLA on an ongoing basis. This benefits the company as the submissions can be reviewed by the FDA as early as possible. Iovance expects the rolling submission to be completed by fourth-quarter 2022.
Lifileucel was granted a regenerative medicine advanced therapy (RMAT) designation by the FDA for advanced melanoma indication in 2018. Therapies that are granted RMAT designation must be intended to treat serious or life-threatening conditions. If a candidate is designated as RMAT, it will enjoy all benefits of fast-track and breakthrough therapy designations.
Lifileucel is also being evaluated in other clinical studies. Iovance intends to start a phase III study later this year to evaluate lifileucel in combination with Merck’s (MRK - Free Report) blockbuster PD-1 inhibitor Keytruda (pembrolizumab). The late-stage study will evaluate the lifileucel-pembrolizumab combo as apotential treatment for immune checkpoint inhibitor naïve frontline metastatic melanoma. IOVA already evaluated this combination for the given indication in a cohort of the phase II study (IOV-COM-202). Data from the cohort demonstrated an overall response rate of 67%.
A multi-center study, IOV-COM-202 is composed of seven cohorts evaluating Iovance’s TIL therapies in multiple settings and for several indications, both as a monotherapy and in combination with Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.
A key revenue generator for Merck, Keytruda is approved for the treatment of many cancer indications, globally. During second-quarter 2022, MRK recorded $5.3 billion worth of sales from Keytruda. MRK is also evaluating Keytruda across a wide number of indications. The studies are progressing well.
Opdivo and Yervoy are two of the many blockbuster drugs marketed by Bristol Myers. Both drugs are key top-line drivers for BMY. In second-quarter 2022, Bristol Myers generated $2.1 billion from Opdivo sales and recorded $525 million as product revenues from Yervoy.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Iovance currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Morphic (MORF - Free Report) , which has a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.75. Loss estimates for 2023 have narrowed from $3.91 to $3.77 during the same period. Shares of Morphic have lost 33.9% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.