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Iovance (IOVA) Falls After Clinical Update on Lung Cancer Drug
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Shares of Iovance Biotherapeutics, Inc. (IOVA - Free Report) were down 18.7% on Dec 27 after the company announced a clinical update on its tumor infiltrating lymphocyte ("TIL") therapy, LN-145, in the non-small cell lung cancer (“NSCLC”) indication.
The phase II IOV-LUN-202 study is currently evaluating LN-145 for treating patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable/metastatic) NSCLC.
On Dec 22, 2023, the FDA placed a clinical hold on the IOV-LUN-202 study following a grade 5 (fatal) serious adverse effect, potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen observed in the study.
Owing to the clinical hold, IOVA will pause the enrollment of new patients in the IOV-LUN-202 study. This is likely to delay the clinical advancement of LN-145 in the NSCLC indication.
Per management, patients who have already undergone tumor resection in the LN-145 TIL treatment regimen will continue to receive the same with extra precautions and risk mitigations.
Shares of Iovance have rallied 15.3% in the past year against the industry’s decline of 15%.
Image Source: Zacks Investment Research
Per the press latest release, the clinical hold on the IOV-LUN-202 study will not affect Iovance’s biologics license application (BLA) for the lead pipeline drug, lifileucel, in the advanced melanoma indication. The clinical hold will also not affect the company’s other ongoing clinical studies.
In May 2023, the FDA accepted IOVA’s BLA submission for lifileucel in melanoma. The BLA seeks accelerated approval for lifileucel to treat patients with advanced unresectable or metastatic melanoma, which progressed on or after prior anti-PD-1/L1 therapy.
With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on Feb 24, 2024.
In June 2023, Iovance randomized the first patient in the phase III TILVANCE-301 study, evaluating the combination of lifileucel and Merck’s blockbuster PD-L1 inhibitor, Keytruda, to treat immune checkpoint inhibitor naïve frontline metastatic melanoma. This late-stage study will also serve as a confirmatory study at the time of seeking full approval for the above BLA.
Regulatory filings for lifileucel in the melanoma indication in Canada and Europe are expected in 2024.
In the past 60 days, estimates for Taro Pharmaceutical’s 2024 earnings per share have improved from 96 cents to $1.10. In the past year, shares of TARO have surged 42.6%.
Earnings of Taro Pharmaceutical beat estimates in two of the last four quarters while missing the same on the remaining two occasions. TARO delivered a four-quarter earnings surprise of 10.06%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have surged 19.6%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining one occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 56 cents to 64 cents. In the past year, shares of PBYI have gained 4.3%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining one occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Iovance (IOVA) Falls After Clinical Update on Lung Cancer Drug
Shares of Iovance Biotherapeutics, Inc. (IOVA - Free Report) were down 18.7% on Dec 27 after the company announced a clinical update on its tumor infiltrating lymphocyte ("TIL") therapy, LN-145, in the non-small cell lung cancer (“NSCLC”) indication.
The phase II IOV-LUN-202 study is currently evaluating LN-145 for treating patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable/metastatic) NSCLC.
On Dec 22, 2023, the FDA placed a clinical hold on the IOV-LUN-202 study following a grade 5 (fatal) serious adverse effect, potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen observed in the study.
Owing to the clinical hold, IOVA will pause the enrollment of new patients in the IOV-LUN-202 study. This is likely to delay the clinical advancement of LN-145 in the NSCLC indication.
Per management, patients who have already undergone tumor resection in the LN-145 TIL treatment regimen will continue to receive the same with extra precautions and risk mitigations.
Shares of Iovance have rallied 15.3% in the past year against the industry’s decline of 15%.
Per the press latest release, the clinical hold on the IOV-LUN-202 study will not affect Iovance’s biologics license application (BLA) for the lead pipeline drug, lifileucel, in the advanced melanoma indication. The clinical hold will also not affect the company’s other ongoing clinical studies.
In May 2023, the FDA accepted IOVA’s BLA submission for lifileucel in melanoma. The BLA seeks accelerated approval for lifileucel to treat patients with advanced unresectable or metastatic melanoma, which progressed on or after prior anti-PD-1/L1 therapy.
With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on Feb 24, 2024.
In June 2023, Iovance randomized the first patient in the phase III TILVANCE-301 study, evaluating the combination of lifileucel and Merck’s blockbuster PD-L1 inhibitor, Keytruda, to treat immune checkpoint inhibitor naïve frontline metastatic melanoma. This late-stage study will also serve as a confirmatory study at the time of seeking full approval for the above BLA.
Regulatory filings for lifileucel in the melanoma indication in Canada and Europe are expected in 2024.
Zacks Rank & Stocks to Consider
Iovance currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Taro Pharmaceutical Industries Ltd. , Entrada Therapeutics, Inc. (TRDA - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting 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 60 days, estimates for Taro Pharmaceutical’s 2024 earnings per share have improved from 96 cents to $1.10. In the past year, shares of TARO have surged 42.6%.
Earnings of Taro Pharmaceutical beat estimates in two of the last four quarters while missing the same on the remaining two occasions. TARO delivered a four-quarter earnings surprise of 10.06%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have surged 19.6%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining one occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 56 cents to 64 cents. In the past year, shares of PBYI have gained 4.3%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining one occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.