MorphoSys US Inc., a fully owned subsidiary of MorphoSys AG (NASDAQ: MOR), and Incyte (NASDAQ: INCY) today announced additional real-world evidence results from the RE-MIND2 study comparing tafasitamab (Monjuvi®) in combination with lenalidomide against the most frequently used treatments in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). These treatments include polatuzumab vedotin plus bendamustine and rituximab (Pola-BR), rituximab plus lenalidomide (R2), and CD19 chimeric antigen receptor T-cell (CAR-T) therapies. The data, which builds on the primary analysis presented at the 2021 Annual Meeting of the Society of Hematologic Oncology (SOHO 2021), will be presented as an oral presentation at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021), held December 11-14, 2021 in Atlanta, Georgia and virtually.

“In this retrospective cohort analysis, a statistically significant OS difference was observed, favoring tafasitamab plus lenalidomide over pola-BR and R2 in patients with relapsed or refractory DLBCL who are ineligible for transplant – a traditionally difficult-to-treat population,” said Grzegorz Nowakowski, M.D., Professor of Medicine and Oncology at the Mayo Clinic, and lead investigator for the RE-MIND2 study*. “I am encouraged by the OS difference favoring tafasitamab plus lenalidomide and the comparable OS between tafasitamab and lenalidomide and CAR-T, specifically the potential prolonged survival benefit the tafasitamab plus lenalidomide combination may offer my patients.”

Findings from the RE-MIND2 study presented at ASH 2021 indicated that tafasitamab plus lenalidomide resulted in statistically significant differences across several endpoints. Specifically, results showed:

• The primary endpoint, overall survival (OS), was met with significant improvement observed for tafasitamab plus lenalidomide at 20.1 months compared to Pola-BR at 7.2 months (p=0.038), and 24.6 months for tafasitamab plus lenalidomide compared to 7.4 months for R2 (p=0.014).
• A comparable median OS benefit was observed with tafasitamab plus lenalidomide at 22.5 months compared to CAR-T at 15 months without statistical significance.
• Objective response rate (ORR), a key secondary endpoint, was observed with statistical significance for tafasitamab plus lenalidomide at 63.6% versus R2 at 30.3% (p=0.013).
• Tafasitamab plus lenalidomide also achieved significantly higher complete response rate (CR), a key secondary endpoint, at 39.4% versus 15.2% for R2 (p=0.0514).
• While safety endpoints were not included in this study, the most common adverse events (AEs) associated with tafasitamab plus lenalidomide are feeling tired or weak, diarrhea, cough, fever, swelling of lower legs or hands, respiratory tract infection and decreased appetite.

Of 3,454 patients enrolled from 200 sites, 106, 106 and 149 patients were treated with pol-BR, R2 and CAR-T, respectively. For the comparative analysis, matched patient pairs were created using 1:1 nearest neighbor matching with a caliper. Matched pairs consisted of: tafasitamab + len vs pol-BR, n=24 pairs; vs R2, n=33; and vs CAR-T, n=37 pairs.

“The RE-MIND 2 Study is an example of our continued commitment to generating practice relevant real-world evidence which, in general, more realistically captures the clinical heterogeneity in cancer and allows us expanded opportunities to dynamically assess the patient experience. These data indicate that tafasitamab plus lenalidomide is a meaningful option for patients and has the potential to become a future backbone therapy in DLBCL,” said Nuwan Kurukulasuriya, Ph.D., Senior Vice President, Global Head of Medical Affairs, MorphoSys.

“We are pleased to see the survival benefit for patients with relapsed or refractory DLBCL in the data from the RE-MIND2 study,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. “As we continue to establish tafasitamab in combination with lenalidomide as the standard of care in second-line treatment for DLBCL, we look forward to exploring the body of clinical evidence and bringing this novel treatment to patients with DLBCL and potentially even to other indications.”

Presentations are available on the ASH website at https://www.hematology.org/meetings/annual-meeting; #183 (oral presentation).

In July 2020, the U.S. Food and Drug Administration (FDA) approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on ORR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The U.S. approval is based on an efficacy subgroup of 71 patients confirmed by central lab. The FDA decision represented the first approval of a second-line treatment for adult patients with DLBCL who progressed during or after first-line therapy.

About Diffuse Large B-cell Lymphoma (DLBCL)

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide1, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter2, leading to a high medical need for new, effective therapies3, especially for patients who are not eligible for an autologous stem cell transplant in this setting.

About RE-MIND2

The RE-MIND2 study is an observational, retrospective cohort study (NCT04697160) that compares outcomes with those from the L-MIND study for autologous stem cell transplant (ASCT)-ineligible patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), who are treated with therapies recommended by the National Comprehensive Cancer Network/European Society for Medical Oncology (NCCN/ESMO). The study utilized real-world data to generate external comparators for patients in the L-MIND trial. The primary analysis of the study compared patient outcomes from L-MIND with matched patient populations treated with gemcitabine-oxaliplatin plus rituximab (R-GemOx), bendamustine and rituximab (BR) and pooled systemic NCCN/ESMO recommended therapies. The additional analysis evaluated tafasitamab in combination with lenalidomide versus Pola-BR, R2 and CAR-T therapies. Patients enrolled in the study were aged 18 years or older with histologically confirmed DLBCL and had received two or more systemic therapies for DLBCL, including one or more anti-CD20 therapy. The study’s primary endpoint is overall survival (OS). Secondary outcome measures include overall response rate (ORR), complete response rate (CRR), duration of response (DoR), event-free survival (EFS), progression-free survival (PFS), time to next treatment (TTNT), treatment discontinuation rate due to adverse events and duration of treatment exposure.

For more information about RE-MIND2, visit https://clinicaltrials.gov/ct2/show/NCT04697160.

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi® (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S., and marketed by Incyte under the brand name Minjuvi® in the EU.

XmAb® is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

• Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, rash, flushing, headache, or shortness of breath during an infusion of MONJUVI.
• Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
• Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

• Feeling tired or weak
• Diarrhea
• Cough
• Fever
• Swelling of lower legs or hands
• Respiratory tract infection
• Decreased appetite

These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

• Have an active infection or have had one recently.
• Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
  • You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
• Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.