Incyte INCY announced positive results from the late-stage study on retifanlimab.

The phase III POD1UM-304 study is evaluating retifanlimab in combination with platinum-based chemotherapy for the treatment of adults with previously untreated non-squamous and squamous metastatic non-small cell lung cancer (NSCLC) not harboring a driver mutation.

The POD1UM-304 study met the primary endpoint of overall survival (OS) and all secondary endpoints in patients with previously untreated metastatic NSCLC.

Shares of Incyte have risen 20.9% year to date against the industry’s 7.5% decline.

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More on INCY’s Study on Retifanlimab

Results from the POD1UM-304 study showed a clinically meaningful and statistically significant improvement over chemotherapy alone.

Patients in the retifanlimab and chemotherapy combination treatment group achieved a median OS of 18.1 months compared to 13.4 months in the placebo and chemotherapy combination group.

The study also met secondary endpoints. Patients who received retifanlimab in combination with chemotherapy had a two-month improvement in median progression-free survival compared to the placebo and chemotherapy combination group.

Both the overall response rate and duration of response by Blinded Independent Central Review showed improvement in the retifanlimab and chemotherapy combination treatment group versus the placebo and chemotherapy combination group.

Retifanlimab was generally well-tolerated and no new safety issue was identified.

The positive results from the POD1UM-304 study support retifanlimab in combination with chemotherapy as an additional treatment option for previously untreated metastatic NSCLC.

We remind investors that retifanlimab, an intravenous PD-1 inhibitor, is indicated in the United States for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In Europe, Zynyz is approved as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy.

Zynyz is marketed by Incyte in the United States. The company entered into an exclusive collaboration and license agreement with MacroGenics, Inc. in 2017 for global rights to retifanlimab.

INCY’s Heavy Dependence on Jakafi

Incyte’s lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and above.

Sales in all indications continue to be strong and should maintain momentum.

While the uptake of the recently approved drugs has been good and a potential approval of the additional drugs should diversify INCY’s portfolio, the company is heavily dependent on Jakafi for its top-line growth.

Competition has increased for some of Jakafi’s approved indications. The FDA’s approval of GSK plc’s GSK Ojjaara for the treatment of intermediate or high-risk MF, including primary MF or secondary MF (post-polycythemia vera and post-essential thrombocythaemia), in adults with anemia, poses a concern.

Jakafi is also expected to lose patent protection in a few years. Hence, the successful development of new drugs is imperative to INCY.

INCY’s Zacks Rank & Stocks to Consider

Incyte currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR and Castle Biosciences, Inc. CSTL, each carrying 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 Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time frame. Year to date, shares of IMCR have lost 54.6%.

IMCR’s earnings beat estimates in two of the trailing four quarters and missed the same in the other two, the average surprise being 25.57%.

In the past 60 days, estimates for Castle Biosciences’ 2025 loss per share have narrowed from $2.13 to $1.88. Year to date, shares of CSTL have surged 46.1%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.



 

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