DGAP-News: MorphoSys AG / Key word(s): Miscellaneous
MorphoSys and Incyte Announce Three-Year Results from Phase 2 L-MIND Study of Tafasitamab in Combination with
Lenalidomide for the Treatment of Relapsed or Refractory DLBCL
2021-06-04 / 19:32
The issuer is solely responsible for the content of this announcement.
=----------------------------------------------------------------------------------------------------------------------
Media Release
MorphoSys and Incyte Announce Three-Year Results from Phase 2 L-MIND Study of Tafasitamab in Combination with
Lenalidomide for the Treatment of Relapsed or Refractory DLBCL
Presentation will be available on demand as part of the 2021 American Society of Clinical Oncology (ASCO) Annual
Meeting
BOSTON, Mass., USA and WILMINGTON, Del., USA - June 4, 2021 - MorphoSys US Inc., a fully owned subsidiary of MorphoSys
AG (FSE: MOR; NASDAQ: MOR), and Incyte (NASDAQ:INCY) today announced new three-year follow-up data from the ongoing
Phase 2 L-MIND study of tafasitamab (Monjuvi^(R)) in combination with lenalidomide in adult patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL). A total of 80 out of 81 enrolled study patients receiving tafasitamab
plus lenalidomide were included in the efficacy analysis at approximately three years follow-up (>=35 months).^[1] The
long-term analysis, as assessed by an independent review committee (IRC), showed that patients treated with tafasitamab
plus lenalidomide had an overall response rate (ORR) of 57.5% (95% CI = 45.9%, 68.5%; 46 out of 80 patients), including
a complete response (CR) rate of 40% (32 out of 80 patients). Additionally, the median duration of response (DoR) was
43.9 months (95% CI = 26.1, NR), with a median overall survival (OS) of 33.5 months (95% CI = 18.3, NR) and median
progression free survival (PFS) of 11.6 months (95% CI = 6.3, 45.7).
These data (abstract #7513) are available on demand as part of the 2021 American Society of Clinical Oncology (ASCO)
Annual Meeting, held virtually June 4-8, 2021, and will be presented as a poster and poster discussion in the
Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia session.
"The three-year efficacy data, combined with the safety and tolerability profile of tafasitamab, further support a
therapeutic option for patients with relapsed or refractory DLBCL who are ineligible for transplant - a traditionally
difficult-to-treat population," said Gilles Salles, M.D., Ph.D., Lymphoma Service Chief at Memorial Sloan Kettering
Cancer Center, and lead investigator of the L-MIND study^*. "I am encouraged to see the confirmed favorable outcome of
patients in the L-MIND study, which suggest that this combination treatment regimen could potentially offer a paradigm
shift and long-term disease control."
The new results - based on an October 30, 2020 data cut-off - build on previous findings showing durable responses and
a consistent safety profile of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in
autologous stem cell transplantation (ASCT)-ineligible patients with relapsed or refractory DLBCL.
"The three-year follow-up data not only show a durable response and consistent safety profile in patients with relapsed
or refractory DLBCL treated with tafasitamab plus lenalidomide, it also suggests the combination could potentially lead
to durable remission," said Nuwan Kurukulasuriya, Ph.D., Senior Vice President, Global Head of Medical Affairs,
MorphoSys. "We are looking forward to sharing these long-term follow-up findings with the scientific community."
"We are pleased that long-term data from the L-MIND study underscore the clinically-significant durable responses that
are possible with tafasitamab plus lenalidomide as a treatment for relapsed or refractory DLBCL," said Peter Langmuir,
M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "We look forward to continuing to build the body of
clinical evidence supporting tafasitamab as a treatment option for patients with DLBCL, as well as exploring other
potential indications for tafasitamab through our ongoing research and development program."
In July 2020, the U.S. Food and Drug Administration (FDA) approved Monjuvi^(R) (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 worldwide^[2], 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 thereafter^[3], leading to a high medical need for
new, effective therapies^[4], especially for patients who are not eligible for an autologous stem cell transplant in
this setting.
About L-MIND
The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab
and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least
one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are
not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant. The study's primary
endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR),
progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion.
For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085.
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^
(R) 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).
Monjuvi^(R) (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 diffuse large B-cell lymphoma (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 January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and
commercialize tafasitamab globally. Monjuvi^(R) is being co-commercialized by Incyte and MorphoSys in the United
States. Incyte has exclusive commercialization rights outside the United States.
A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the
European Union has been validated by the European Medicines Agency (EMA) and is currently under review for the
treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are
not candidates for ASCT.
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing
combination trials.
Monjuvi^(R) is a registered trademark of MorphoSys AG.
XmAb^(R) 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
(MORE TO FOLLOW) Dow Jones Newswires
June 04, 2021 13:33 ET (17:33 GMT)