Incyte aims to expand Monjuvi's use after phase 3 lymphoma success

Incyte Corporation has made significant strides in the oncology field, especially with its anti-CD19 antibody, Monjuvi (tafasitamab). Earlier this year, the company acquired full rights to Monjuvi from its partner MorphoSys for $25 million. This acquisition came after a period of collaboration where Incyte had exclusive rights outside the United States, while both companies jointly handled clinical development and commercialization.

The latest development in Incyte's journey with Monjuvi is promising. In a recent phase 3 clinical trial, Monjuvi, when combined with Bristol Myers Squibb's Revlimid and Roche's Rituxan, met its primary endpoint of progression-free survival in patients with relapsed or refractory follicular lymphoma. The trial's success was measured by investigator assessment and compared the efficacy of the Monjuvi regimen against a control group receiving a combination of placebo, Revlimid, and Rituxan.

Steven Stein, M.D., Incyte’s Chief Medical Officer, emphasized the significance of these findings. He noted that while initial treatments for follicular lymphoma often provide benefits, relapse remains a common issue, highlighting the necessity for new therapeutic options. Stein pointed out that the addition of tafasitamab to the standard treatment regimen could offer a vital new option for patients whose disease has progressed after at least one prior therapy.

With these positive results, Incyte is preparing to seek approval for Monjuvi in treating follicular lymphoma by the end of the year. The targeted patient group includes those who have not responded to at least one previous systemic anti-CD20 immunotherapy or chemotherapy. In addition to filing for approval, the company plans to present the full data at an upcoming scientific meeting, further showcasing the potential of this treatment.

Monjuvi's market performance has also been noteworthy, generating $92 million last year. The potential approval for follicular lymphoma could substantially enhance its market presence. Follicular lymphoma, a slow-growing type of B-cell non-Hodgkin lymphoma, accounts for approximately 13% to 26% of all non-Hodgkin lymphoma cases, highlighting a significant market opportunity.

Incyte is not stopping there. The company is also investigating Monjuvi's efficacy in first-line treatment for relapsed or refractory diffuse large B cell lymphoma and marginal zone lymphoma. These additional studies are crucial for driving further growth, as highlighted by analysts at William Blair.

Monjuvi initially entered the market following an accelerated approval by the FDA in 2020. It was approved for use in combination with Revlimid to treat patients with relapsed or refractory diffuse large B-cell lymphoma. This initial approval set the stage for its current and potential future indications.

MorphoSys had previously estimated that Monjuvi could achieve sales between $80 million and $95 million in 2024. Moreover, the partners had once projected peak U.S. sales ranging from €500 million to €700 million based solely on its current indication. The expanding indications for Monjuvi could significantly push these figures higher, making it a key player in the oncology market.

In summary, Incyte's acquisition of Monjuvi and the positive phase 3 trial results for follicular lymphoma could mark a significant advancement in treatment options for this patient population. With plans to seek further approvals and ongoing studies in other lymphoma subtypes, Monjuvi's future looks promising, both in terms of patient impact and market performance.