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FDA Lifts Clinical Hold on Iovance's (IOVA) Lung Cancer Study
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Iovance Biotherapeutics (IOVA - Free Report) announced that the FDA removed the clinical hold placed on the registrational phase II IOV-LUN-202 study of its investigational tumor-infiltrating lymphocyte (TIL) therapy, LN-145, in certain non-small cell lung cancer (NSCLC) patients.
This clinical hold was placed by the FDA last year in December following a grade 5 (fatal) adverse effect, potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen observed in the study.
The FDA removed the clinical hold after reviewing Iovance’s proposal for additional safety measures and monitoring. To develop these measures, management worked closely with the agency officials and an independent data monitoring committee.
Owing to the clinical hold, IOVA had paused enrollment of new patients in the IOV-LUN-202 study. Following the removal of the hold, management restarted enrolling patients in the study and intends to enroll a total of around 120 patients by the next year.
The IOV-LUN-202 study is evaluating LN-145 for treating patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable/metastatic) NSCLC.
Shares of Iovance have surged 108.6% in the year-to-date period compared with the industry’s 4.2% rise.
Image Source: Zacks Investment Research
Last year in July, Iovance received positive feedback from the FDA on the study design of the IOV-LUN-202 study, indicating accelerated approval for LN-145 in NSCLC indication. Based on the FDA’s feedback, Iovance completed a preliminary analysis of the IOV-LUN-202 study that included 23 NSCLC patients who received LN-145. Data from the study showed that as of Jul 6, 2023, the study achieved an objective response rate (ORR) of 26.1% (including one complete and five partial responses) and a disease control rate of 82.6%.
The FDA lifting the clinical hold is the latest good news for Iovance this year. Last month, Iovance received FDA approval for the TIL therapy Amtagvi (lifileucel). The FDA accelerated approval for Amtagvi to treat adult patients with advanced melanoma that progressed on or after prior anti-PD-1/L1 and targeted therapy.
Following the approval, Amtagvi became the first and the only one-time T-cell therapy to be approved by the FDA for treating solid tumor cancer and also the first treatment option in this melanoma indication. A commercial launch is currently underway.
Iovance currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Adicet Bio (ACET - Free Report) , ADMA Biologics (ADMA - Free Report) and Puma Biotechnology (PBYI - Free Report) . While ADMA each sports a Zacks Rank #1 (Strong Buy) at present, Adicet and Puma carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 18 cents to 25 cents. Meanwhile, during the same period, EPS estimates for 2025 have improved from 32 cents to 42 cents. Year to date, shares of ADMA have risen 26.6%.
Earnings of ADMA Biologicsbeat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for Adicet Bio’s 2024 loss per share have improved from $2.11 to $1.81. Year to date, shares of ACET have rallied 25.9%.
Adicet Bio's earnings beat estimates in two of the trailing four quarters while missing the mark on the other two occasions. On average, Adicet's four-quarter negative earnings surprise was 8.36%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 EPS have risen from 69 cents to 71 cents. During the same period, earnings per share estimates for 2024 have improved from 80 cents to 81 cents. Year to date, shares of PBYI have rallied 23.8%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on one occasion. Puma delivered a four-quarter average earnings surprise of 147.49%.
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FDA Lifts Clinical Hold on Iovance's (IOVA) Lung Cancer Study
Iovance Biotherapeutics (IOVA - Free Report) announced that the FDA removed the clinical hold placed on the registrational phase II IOV-LUN-202 study of its investigational tumor-infiltrating lymphocyte (TIL) therapy, LN-145, in certain non-small cell lung cancer (NSCLC) patients.
This clinical hold was placed by the FDA last year in December following a grade 5 (fatal) adverse effect, potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen observed in the study.
The FDA removed the clinical hold after reviewing Iovance’s proposal for additional safety measures and monitoring. To develop these measures, management worked closely with the agency officials and an independent data monitoring committee.
Owing to the clinical hold, IOVA had paused enrollment of new patients in the IOV-LUN-202 study. Following the removal of the hold, management restarted enrolling patients in the study and intends to enroll a total of around 120 patients by the next year.
The IOV-LUN-202 study is evaluating LN-145 for treating patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable/metastatic) NSCLC.
Shares of Iovance have surged 108.6% in the year-to-date period compared with the industry’s 4.2% rise.
Image Source: Zacks Investment Research
Last year in July, Iovance received positive feedback from the FDA on the study design of the IOV-LUN-202 study, indicating accelerated approval for LN-145 in NSCLC indication. Based on the FDA’s feedback, Iovance completed a preliminary analysis of the IOV-LUN-202 study that included 23 NSCLC patients who received LN-145. Data from the study showed that as of Jul 6, 2023, the study achieved an objective response rate (ORR) of 26.1% (including one complete and five partial responses) and a disease control rate of 82.6%.
The FDA lifting the clinical hold is the latest good news for Iovance this year. Last month, Iovance received FDA approval for the TIL therapy Amtagvi (lifileucel). The FDA accelerated approval for Amtagvi to treat adult patients with advanced melanoma that progressed on or after prior anti-PD-1/L1 and targeted therapy.
Following the approval, Amtagvi became the first and the only one-time T-cell therapy to be approved by the FDA for treating solid tumor cancer and also the first treatment option in this melanoma indication. A commercial launch is currently underway.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Zacks Rank & Key Picks
Iovance currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Adicet Bio (ACET - Free Report) , ADMA Biologics (ADMA - Free Report) and Puma Biotechnology (PBYI - Free Report) . While ADMA each sports a Zacks Rank #1 (Strong Buy) at present, Adicet and Puma carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 18 cents to 25 cents. Meanwhile, during the same period, EPS estimates for 2025 have improved from 32 cents to 42 cents. Year to date, shares of ADMA have risen 26.6%.
Earnings of ADMA Biologicsbeat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for Adicet Bio’s 2024 loss per share have improved from $2.11 to $1.81. Year to date, shares of ACET have rallied 25.9%.
Adicet Bio's earnings beat estimates in two of the trailing four quarters while missing the mark on the other two occasions. On average, Adicet's four-quarter negative earnings surprise was 8.36%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 EPS have risen from 69 cents to 71 cents. During the same period, earnings per share estimates for 2024 have improved from 80 cents to 81 cents. Year to date, shares of PBYI have rallied 23.8%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on one occasion. Puma delivered a four-quarter average earnings surprise of 147.49%.