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Iovance (IOVA) Completes Rolling BLA Filing for Melanoma Drug
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Shares of Iovance Biotherapeutics (IOVA - Free Report) were up 11.0% in pre-market trading on Mar 27 after management announced that it had completed the filing of its rolling biologics license application (BLA) for lifileucel, its lead pipeline candidate.
The BLA seeks accelerated approval for lifileucel to treat patients with advanced unresectable or metastatic melanoma, which has progressed on or after prior anti-PD-1/L1 therapy.
The filing is based on data from cohorts 2 and 4 of the phase II C-144-01 study, which evaluated lifileucel in patients with post-anti-PD1 melanoma. Overall data from these cohorts shows that treatment with lifileucel achieved an objective response rate (ORR) of 31%, with the median duration of the response still not reached at 36.5 months.
Following the receipt of the BLA, the FDA now has 60 days to accept Iovance’s BLA for review. The BLA is also eligible for priority review by the agency.
If the BLA is approved, lifileucel will be the first FDA-approved individualized, one-time cell therapy for melanoma patients. 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 declined 13.5% compared with the industry’s 6.0% fall.
Image Source: Zacks Investment Research
Lifileucel became eligible for a rolling submission after lifileucel was granted regenerative medicine advanced therapy (RMAT) designation by the FDA in advanced melanoma in 2021. A candidate, granted RMAT designation by the agency, is eligible to enjoy all the benefits of fast-track and breakthrough therapy designations.
Earlier this January, management also announced that it had reached an agreement with the FDA on the scope of the phase III TILVANCE-301 study, which will evaluate the combination of lifileucel and Merck’s (MRK - Free Report) PD-L1 inhibitor Keytruda (pembrolizumab) against Merck’s Keytruda in frontline metastatic melanoma. This late-stage study, which will start later this year, will serve as a confirmatory study for the above BLA. Iovance already evaluated the combination of lifileucel and Merck’s Keytruda for the given indication in a cohort of the phase II IOV-COM-202 study. Data from the cohort demonstrated an overall response rate (ORR) 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, as a monotherapy and in combination with Merck’s Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.
Opdivo and Yervoy are two of the many blockbuster drugs marketed by Bristol Myers. Both drugs are key top-line drivers for Bristol Myers. During 2022, Bristol Myers generated $8.2 billion from Opdivo sales and recorded $2.1 billion as product revenues from Yervoy.
In the past 30 days, estimates for Certara’s 2023 earnings per share have increased from 46 cents to $1.24. During the same period, the earnings estimates per share for 2024 have risen from 54 cents to $1.85. Shares of Certara are up 47.2% in the year-to-date period.
Earnings of Certara missed estimates in two of the last four quarters, beating the mark on one occasion while meeting the mark on another. On average, the company’s earnings witnessed a negative surprise of 3.25%. In the last reported quarter, Certara’s earnings beat estimates by 14.29%.
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Iovance (IOVA) Completes Rolling BLA Filing for Melanoma Drug
Shares of Iovance Biotherapeutics (IOVA - Free Report) were up 11.0% in pre-market trading on Mar 27 after management announced that it had completed the filing of its rolling biologics license application (BLA) for lifileucel, its lead pipeline candidate.
The BLA seeks accelerated approval for lifileucel to treat patients with advanced unresectable or metastatic melanoma, which has progressed on or after prior anti-PD-1/L1 therapy.
The filing is based on data from cohorts 2 and 4 of the phase II C-144-01 study, which evaluated lifileucel in patients with post-anti-PD1 melanoma. Overall data from these cohorts shows that treatment with lifileucel achieved an objective response rate (ORR) of 31%, with the median duration of the response still not reached at 36.5 months.
Following the receipt of the BLA, the FDA now has 60 days to accept Iovance’s BLA for review. The BLA is also eligible for priority review by the agency.
If the BLA is approved, lifileucel will be the first FDA-approved individualized, one-time cell therapy for melanoma patients. 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 declined 13.5% compared with the industry’s 6.0% fall.
Image Source: Zacks Investment Research
Lifileucel became eligible for a rolling submission after lifileucel was granted regenerative medicine advanced therapy (RMAT) designation by the FDA in advanced melanoma in 2021. A candidate, granted RMAT designation by the agency, is eligible to enjoy all the benefits of fast-track and breakthrough therapy designations.
Earlier this January, management also announced that it had reached an agreement with the FDA on the scope of the phase III TILVANCE-301 study, which will evaluate the combination of lifileucel and Merck’s (MRK - Free Report) PD-L1 inhibitor Keytruda (pembrolizumab) against Merck’s Keytruda in frontline metastatic melanoma. This late-stage study, which will start later this year, will serve as a confirmatory study for the above BLA. Iovance already evaluated the combination of lifileucel and Merck’s Keytruda for the given indication in a cohort of the phase II IOV-COM-202 study. Data from the cohort demonstrated an overall response rate (ORR) 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, as a monotherapy and in combination with Merck’s Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.
Opdivo and Yervoy are two of the many blockbuster drugs marketed by Bristol Myers. Both drugs are key top-line drivers for Bristol Myers. During 2022, Bristol Myers generated $8.2 billion from Opdivo sales and recorded $2.1 billion as product revenues from Yervoy.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Zacks Rank & Stock to Consider
Iovance currently carries a Zacks Rank #3 (Hold). Another better-ranked stock in the overall healthcare sector is Certara (CERT - Free Report) , which sports 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 Certara’s 2023 earnings per share have increased from 46 cents to $1.24. During the same period, the earnings estimates per share for 2024 have risen from 54 cents to $1.85. Shares of Certara are up 47.2% in the year-to-date period.
Earnings of Certara missed estimates in two of the last four quarters, beating the mark on one occasion while meeting the mark on another. On average, the company’s earnings witnessed a negative surprise of 3.25%. In the last reported quarter, Certara’s earnings beat estimates by 14.29%.