Iovance Biotherapeutics
IOVA
announced data from the pivotal Cohort 4 of the phase II C-144-01 study on its lead candidate lifileucel, which is being evaluated in heavily pre-treated melanoma patients.
Per an independent review committee (IRC),data from the pivotal cohort 4 demonstrated that participants who were administered lifileucel 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.
Data from the cohort 2 of the study 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.
Shares of Iovance plunged more than 40% in pre-market trading on Friday following the news announcement. Investors were likely not impressed with the response data as the pivotal cohort 4 outcome was lower than that of the supportive cohort 2 of the study.
Shares of Iovance have fallen 20.8% in the year-to-date period compared with the
industry
’s 23.8% decline.
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However, Iovance also pointed out that data from the cohort 4 showed a higher baseline disease burden than the patients in cohort 2,including higher lactate dehydrogenase (LDH) levels and a greater number of tumor lesions at baseline. The safety profile was also consistent between both cohorts.
Data from both cohort 2 and cohort 4 also demonstrate that a one-time treatment with lifileucel has the potential to provide meaningful benefits to heavily pre-treated patients. In fact, the combined pool of data from both cohorts demonstrates that lifileucel achieved an ORR of 31% at a median study follow-up of 27.6 months. Management plans to report additional data from both cohorts at a future medical meeting.
Iovance plans to use the data from the registrational cohort 4 of the C-144-01 study to file a biologics license application (BLA) come August with the FDA, seeking approval for lifileucel to address the melanoma indication. The BLA filing will also be supported by the cohort 2 of the study.
Iovance intends to start a phase III study later this year for evaluating lifileucel in combination with
Merck
’s
MRK
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
Opdivo/Yervoy.
A key revenue generator for Merck, Keytruda is approved for the treatment of many cancer indications, globally. During first-quarter 2022, MRK recorded $4.8 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 first-quarter 2022, Bristol Myers generated $1.9 billion from Opdivo sales and recorded $515 million as product revenues from Yervoy.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price
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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
Alkermes
ALKS
, which has a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Alkermes’ loss per share estimates for 2022 have narrowed from 10 cents to 3 cents in the past 30 days. Shares of ALKS have risen 26.2% year to date.
Earnings of Alkermesbeat estimates in each of the last four quarters, the average being 350.5%. In the last reported quarter, Alkermes delivered an earnings surprise of 1,100%.
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