INCY's Phase III Monjuvi Study Meets Key Goals in First-Line Lymphoma

Incyte INCY announced positive top-line results from a late-stage lymphoma study of Monjuvi/Minjuvi (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in the first-line setting.

The drug, in combination with Bristol Myers’ BMY Revlimid (lenalidomide), is approved in the United States and the EU under the brand names Monjuvi and Minjuvi, respectively, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The eligible patient population included cases arising from low-grade lymphoma, who are ineligible for autologous stem cell transplant.

More recently, the FDA approved Incyte’s Monjuvi in combination with BMY’s Revlimid and Roche’s Rituxan (rituximab) in mid-2025 for adult patients with relapsed or refractory follicular lymphoma (FL). Last month, the regulatory body in the EU also approved the label expansion of Minjuvi for patients with relapsed or refractory FL, further expanding its presence across hematologic malignancies.

Data From INCY’s First-Line DLBCL Study of Monjuvi/Minjuvi

Incyte’s pivotal phase III frontMIND study evaluating the efficacy and safety of Monjuvi/Minjuvi and Bristol Myers’ Revlimid in combination with R-CHOP (Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone) compared to R-CHOP alone as a first-line treatment for adults with newly diagnosed DLBCL.

The intended patient population included 900 adults with previously untreated DLBCL with an International Prognostic Index (IPI) score of three to five for patients more than 60 years of age, or an age-adjusted IPI of two to three for patients aged 60 years or less.

According to the data readout, the frontMIND study met its primary endpoint, demonstrating a statistically meaningful improvement in progression-free survival as assessed by investigators using the Lugano 2014 criteria. The study also achieved its key secondary endpoint of event-free survival, with no new or unexpected safety signals reported.

Incyte’s shares have surged 51.3% in the past six months compared with the industry’s growth of 21.5%.

The results underscore the potential of adding Monjuvi/Minjuvi and BMY’s Revlimid to R-CHOP as a more effective first-line treatment option for newly diagnosed DLBCL patients. Management noted that, despite progress in DLBCL treatment, many high-risk patients still have poor outcomes, and this combination could improve cure rates if used as a first-line therapy, marking an important step forward in treatment standards.

Based on these encouraging findings, Incyte plans to submit a supplemental biologics license application to the FDA seeking the label expansion of Monjuvi for the first-line treatment of adults with newly diagnosed DLBCL in the first half of 2026. The company intends to present detailed data from the frontMIND study at an upcoming scientific meeting.

Per Incyte, DLBCL is the most common type of non-Hodgkin lymphoma in adults, accounting for about 40% of cases worldwide. It is an aggressive, fast-growing cancer that can arise in lymph nodes or extranodal sites, with roughly 24,000 new diagnoses each year in the United States and up to 36,000 in the EU. Despite available treatments, around 40% of patients relapse or fail initial therapy, underscoring a significant unmet medical need for more effective options.

Incyte Corporation Price and Consensus

Incyte Corporation price-consensus-chart | Incyte Corporation Quote

INCY’s Zacks Rank & Stocks to Consider

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

Some better-ranked stocks from the sector are ANI Pharmaceuticals ANIP and CorMedix CRMD, 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 ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $7.29 to $7.56. EPS estimates for 2026 have increased from $7.81 to $8.08 during the same period. In the past six months, shares of ANIP have risen nearly 21.2%.

ANIP’s earnings beat estimates in the trailing four quarters, delivering an average surprise of 21.24%.

Estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87 over the past 60 days, while the same for 2026 has increased from $2.49 to $2.88. CRMD shares have gained 6.8% in the past six months.

CorMedix’s earnings beat estimates in the trailing four quarters, delivering an average surprise of 27.04%.

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