On December 27, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies (Press release, BeiGene, DEC 27, 2019, View Source [SID1234552622]). The new drug application (NDA) was previously granted priority review by the NMPA. Following the recent approval of BRUKINSA (zanubrutinib) by the U.S. Food and Drug Administration (FDA), tislelizumab is BeiGene’s first drug approved in China.

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Developed by BeiGene scientists, tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR, which is believed to play an essential role in activating phagocytosis in macrophages to minimize its negative impact on T effector cells.

"We’ve been working to develop improved therapies for cancer patients around the world. The discovery of immunotherapy revolutionized the cancer treatment paradigm and has since brought new treatment options and hope to people with cancer," commented John V. Oyler, Chairman, Co-Founder, and CEO of BeiGene. "Tislelizumab is a differentiated anti-PD-1 antibody and has demonstrated encouraging clinical efficacy and safety in patients with relapsed/refractory cHL. We look forward to its further development in a broad array of solid tumors and hematological malignancies."

Professor Jun Zhu, M.D., Ph.D., Director of the Lymphoma Department at Beijing Cancer Hospital commented, "Anti-PD-1 antibodies are becoming a new treatment option for lymphoma patients. With a complete response rate of more than 60%, BeiGene’s tislelizumab has demonstrated significant efficacy and a good safety profile as a monotherapy in patients with relapsed/refractory cHL. The approval of tislelizumab will bring a meaningful treatment option for those patients with cHL in China."

"Currently, BeiGene is conducting 15 registration-enabling clinical trials to evaluate tislelizumab in 23 countries and regions globally in prevalent cancer types such as lung, liver, esophageal and gastric cancers, with over 4,800 patients enrolled to date in its broad development program. We are grateful to the dedicated clinicians and particularly the patients who participated in these clinical studies," said Wendy Yan, Senior Vice President and Global Head of Regulatory Affairs at BeiGene.

In addition, a supplementary new drug application (sNDA) for tislelizumab in patients with previously treated locally advanced or metastatic urothelial carcinoma has been accepted and granted priority review by the Center for Drug Evaluation (CDE) at the NMPA.

Tislelizumab is a biologic product approved under the Marketing Authorization Holder (MAH) pilot program in China, and will be manufactured by Boehringer Ingelheim at its facility in Shanghai as the commercial supplier. Established in 1885, Boehringer Ingelheim has over 35 years of biotechnology experience, and with more than 3,600 employees and a global network its contract biopharmaceutical manufacturing business has helped to bring more than 30 molecules to the market globally.

The NMPA approval is based on the clinical results from a single-arm, multi-center, pivotal Phase 2 trial BGB-A317-203 (NCT03209973). Among the patients who were evaluable for responses, with a minimum follow-up of 12 months and a median follow-up of 14 months, the independent review committee (IRC)-assessed objective response rate (ORR) was 76.9% and the complete response (CR) rate was 61.5%.

In the R/R cHL trial BGB-A317-203, the most common adverse reactions (≥ 10%) reported were pyrexia, hypothyroidism, weight increase, pruritus, decreased white blood cell count, upper respiratory tract infection, increased alanine aminotransferase (ALT), rash, decreased neutrophil count, cough, fatigue, and increased blood bilirubin. Grade 3 and above adverse reactions occurring in ≥ 2% of patients included pneumonitis, weight increase, severe skin reactions and hypertension. There was no fatal adverse reaction case reported from BGB-A317-203.

Like other immune checkpoint inhibitors, tislelizumab could cause immune- related adverse events (irAE) that mainly include pneumonitis, diarrhea and colitis, hepatitis, endocrinopathies (hypothyroidism, hyperthyroidism and other thyroid disorders, adrenocortical insufficiency, hyperglycemia and type 1 diabetes mellitus) and skin adverse reactions. Occasionally, nephritis, pancreatitis, myocarditis and other irAE were also reported.

The recommended dose of tislelizumab is 200 mg administered as an intravenous infusion every three weeks, until disease progression or intolerable toxicity.

BeiGene is currently working with Boehringer Ingelheim to prepare for the commercial supply to launch of tislelizumab in China.

About Classical Hodgkin’s Lymphoma

Hodgkin’s lymphoma is a group of malignancies that affects the lymph nodes and the tissues of the lymphatic system. The most common form is classical Hodgkin’s lymphoma (cHL), which accounts for 95% of all Hodgkin’s lymphoma incidences1. It is most commonly diagnosed in young adults between the ages of 15 and 35 and in older adults over age 552. Enlarged lymph nodes are typically the initial symptom, but cancer cells can be detected in liver, spleen, and bone marrow in late stage disease. Although first-line chemo-radiotherapy has demonstrated significant improvement in the survival of patients with cHL, patients with primary refractory disease (approximately 5-10%) or those who relapse after responding to initial treatment (approximately 10-30%), usually have poor prognosis and traditional treatments have shown limited efficacy, representing an unmet medical need.

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma who received at least two prior therapies. A supplemental new drug application (sNDA) for tislelizumab in patients with previously treated locally advanced or metastatic urothelial carcinoma has been granted priority review by the Center for Drug Evaluation at the NMPA and is currently under review.

Tislelizumab will be manufactured by Boehringer Ingelheim at its facility in Shanghai as the commercial supplier. Following required qualifications and approvals, BeiGene plans to provide additional commercial supply through its commercial-scale biologics manufacturing facility in Guangzhou, which completed its initial phase of construction in September this year.

Tislelizumab is being studied in a broad clinical program as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. Currently, 15 registration-enabling clinical trials are being conducted in China and globally, including 11 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is not approved for use outside China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
Phase 3 trial in patient with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with non-small cell lung cancer (NSCLC; NCT03358875);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).

On December 27, 2019 Mateon Therapeutics Inc. (OTCQB:MATN) reported the publication of a peer-reviewed research article co-authored by Fatih Uckun MD. PhD, the Chief Medical Officer for Mateon, Vuong Trieu, PhD, the Chief Executive Officer and President for Mateon and four hematology/oncology professors from academic US institutions in the prestigious oncology journal Cancers (Basel) (Press release, Mateon Therapeutics, DEC 27, 2019, View Source [SID1234552620]).

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The article describes in detail the data obtained in the recently completed multi-institutional OXI1222 study that was aimed to evaluate the clinical potential of Mateon’s lead anti-leukemia drug Combretastatin A1 (also known as OXi4503) in adult patients with previously treated relapsed acute myeloid leukemia (AML). This clinical study was registered at www.clinicaltrials.gov as NCT02576301. Patients were treated by participating leukemia experts affiliated with the University of Florida, University of Kansas Cancer Center, David Geffen School of Medicine at UCLA, and University of Miami Sylvester Comprehensive Cancer Center, Miami who co-authored the published article. The primary purpose of this Phase 1B study was to define the maximum tolerated dose and safety profile of OXi4503 and cytarabine administered in combination (OXA) in patients with relapsed/refractory AML. The study was completed in August 2019 and met its primary endpoint. The study showed that adding OXi4503 to the standard chemotherapy drug cytarabine was generally well tolerated by AML patients and a maximum tolerated dose level of OXi4503 was identified as the recommended dose for further clinical development of this novel two-drug combination. In 26 evaluable AML patients, there were 4 complete remissions (CR/CRi) and one partial remission (PR). The CR responses were associated with >1-year overall survival times. The combination therapy exhibited a manageable toxicity and a promising benefit to risk profile in older adults with relapsed AML who are in urgent need for effective new therapies. The safety, feasibility, and early clinical activity of this new treatment in relapsed/refractory AML deserves further clinical validation in a randomized registration study.

"This work emphasizes our commitment to find effective new therapies for difficult-to-treat cancers," stated Dr. Vuong Trieu, Chairman and Chief Executive Officer of Mateon Therapeutics.

OXi4503 has received orphan drug designation for AML in both the US and the European Union. Further, the US FDA has granted fast-track designation to OXi4503 for the treatment of relapsed/refractory AML.

"AML is the most common form of adult acute leukemia with >20,000 estimated new cases and >10,000 deaths in the United States (US) for 2019. Despite recent advances in therapy, the five-year overall survival remains < 30% and prognosis is grim in patients who experience a recurrence of their disease after first-line induction therapy, with <10% surviving five years after relapse. The greatest challenge in AML is relapsed or refractory disease. For relapsed or refractory AML, there is no consensus on a single re-induction regimen. By combining OXi4503 with the standard chemotherapy drug cytarabine, we hope to develop an innovative approach that improves outcomes for patients with relapsed AML, especially those who are older and have a dismal prognosis," explained Fatih Uckun, MD, PhD, Chief Medical Officer of Mateon Therapeutics.

The research article "A Phase 1B Clinical Study of Combretastatin A1 Diphosphate (OXi4503) and Cytarabine (ARA-C) in Combination (OXA) for Patients with Relapsed or Refractory Acute Myeloid Leukemia" has been published in Cancers (Basel) as part of the Special Issue Personalized Medicine: Recent Progress in Cancer Therapy and is available online:

Abstract: View Source
PDF Version: View Source/pdf
Special Issue: View Source

On December 27, 2019 Molecular Partners AG (SIX:MOLN), a clinical-stage biotech company pioneering the use of DARPin therapeutics to treat serious diseases, reported the receipt of Orphan Drug Designation by the US Food and Drug Administration (FDA) for its novel therapeutic, MP0250, for the treatment of Multiple Myeloma (Press release, Molecular Partners, DEC 27, 2019, View Source [SID1234552619]).

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MP0250 is a first-in-class, tri-specific multi-DARPin drug candidate neutralizing VEGF-A and HGF and is binding to human serum albumin to increase plasma half-life. The unique mechanism of action of MP0250 represents a new approach to targeting the tumor microenvironment and increase patients’ responses to already approved therapies for multiple myeloma, potentially even after progression.

The mission of the FDA’s Office of Orphan Products Development (OOPD) is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the U.S. In fulfilling that task, the OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. Orphan drug designation provides incentives for sponsors to develop products for rare diseases. These incentives may include a partial tax credit for certain clinical trial expenditures, the waiver of certain FDA user fees, and potential eligibility for seven years of orphan drug marketing exclusivity, if approved.

Financial Calendar
February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates can engage more than five targets, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology and is advancing a proprietary pipeline of DARPin drug candidates in oncology and immuno-oncology. The most advanced global product candidate in partnership with Allergan is abicipar, a molecule for which phase 3 data have been filed to the respective regulators in both the US and in Europe. Several DARPin molecules for various ophthalmic indications are also in preclinical development. The most advanced DARPin therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of hematological tumors. MP0274, the second-most advanced DARPin candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads to induction of apoptosis. MP0274 is currently in phase 1. The company’s lead immuno-oncology product candidate MP0310 is a FAP x 4-1BB multi-DARPin therapeutic candidate designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator). Molecular Partners has closed a collaboration agreement with Amgen for the exclusive clinical development and commercialization of MP0310. The molecule has entered in phase 1 of clinical development in H2 2019. Molecular Partners is also advancing a growing preclinical and research pipeline in immuno-oncology that features its "I/O toolbox" and additional development programs such as novel therapeutic designs to target peptide-MHC complexes. DARPin is a registered trademark owned by Molecular Partners AG.

On December 27, 2019 Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, reported the China National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy (Press release, Zai Laboratory, DEC 27, 2019, View Source [SID1234552618]). ZEJULA is a potent and highly selective PARP1/2 inhibitor that does not require BRCA mutation or other biomarker testing prior to administration.

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"The NMPA approval of ZEJULA, our first product to be approved in Mainland China, is a testament to the hard work and dedication of the entire Zai Lab team," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "We are grateful to all of the patients and investigators who contributed to the success of the ZEJULA clinical development program. Additionally, we appreciate the NMPA for their partnership through this rapid and thorough assessment of the ZEJULA application, recognizing the high unmet medical need it serves. As the first PARP inhibitor with Category 1 designation and manufactured in Mainland China, we are very excited to bring ZEJULA to Chinese patients following the successful launch in Hong Kong. With enrollment completed with 265 patients, we remain committed to finish our pivotal trial for maintenance therapy for Chinese patients with recurrent ovarian cancer (the NORA study) by third quarter of next year."

"The approval of ZEJULA in Mainland China is welcoming news for the ovarian cancer community, where advances in treatment have been very limited despite the clinical need," said Dr. Xiaohua Wu, Professor and Chair of Gynecologic Oncology Department of Fudan University Shanghai Cancer Centre. "The NOVA study shows that ZEJULA is a potential best-in-class PARP inhibitor for ovarian cancer patients, regardless of BRCA mutation or biomarker status, due to its compelling clinical data, convenience of once-daily dosing and attractive pharmacokinetic properties, including its ability to cross the blood brain barrier."

Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164, and Supplementary Appendix.

The Committee of Gynecological Oncology, Chinese Anti-Cancer Association (CACA) has updated its clinical practice guidelines in Consensus of Chinese Experts on Recurrent Epithelial Ovarian Cancer to recommend ZEJULA (I/A category) as a maintenance treatment option for platinum sensitive recurrent ovarian cancer.

"Ovarian cancer is a devastating disease with a 5-year survival rate that hasn’t improved in a decade," said Dr. Lingying Wu, Director of the Department of Gynecologic Oncology of the Cancer Hospital of China Academy of Medical Sciences. "In addition to helping patients with recurrent ovarian cancer, ZEJULA’s recent PRIMA study demonstrated significant PFS improvement when given as monotherapy in women with first-line platinum responsive ovarian cancer, resulting in a 38% reduction in the risk of disease progression or death in the overall study population. Clinically meaningful reduction in risk of disease progression or death was further demonstrated with hazard ratios (HRs) of 0.40, 0.43 and 0.68 for BRCA mutant, HRD positive and HRD negative tumors, respectively. This study showed ZEJULA as the first PARP inhibitor to significantly improve PFS in this setting, regardless of biomarker status."

Zai Lab anticipates filing a supplemental NDA for ZEJULA (niraparib) with the NMPA as a first-line monotherapy maintenance treatment of platinum-responsive ovarian cancer patients soon after GlaxoSmithKline plc (GSK) files with the relevant global health authorities.

Ovarian cancer in China

Ovarian cancer is one of the most common gynecologic cancers in China with more than 52,000 newly diagnosed cases and 23,000 deaths in China each year. The 5-year overall survival rate of ovarian cancer patients is 46% across all stages, but only 29% in patients diagnosed with distant metastatic disease. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. Effective treatment options for patients with platinum-sensitive recurrent ovarian cancer remain limited. New agents that prolong the duration of response following platinum-based treatment and delay the inevitable relapse of ovarian cancer will benefit patients with ovarian cancer in China.

About ZEJULA (niraparib)

ZEJULA (niraparib, ZL-2306) is a potential best-in-class PARP inhibitor for ovarian cancer patients due to its compelling clinical data2, once-daily dosing and pharmacokinetic properties, including its ability to cross the blood brain barrier. As maintenance therapy for recurrent ovarian cancer (the NOVA study), ZEJULA treatment reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (HR 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45).

Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164, and Supplementary Appendix.

Zai Lab also conducted a Phase 1 pharmacokinetic (PK) study of niraparib in Chinese patients with ovarian cancer. This study was published in August 2019 in The Oncologist and demonstrated that the PK profile of niraparib in Chinese patients were comparable to that of patients evaluated in ZEJULA’s global PK study. Zai Lab in-licensed rights to ZEJULA from GSK for Mainland China, Hong Kong and Macau.

The NDA was accepted by the NMPA on December 12, 2018 and granted priority review status on January 29, 2019. Zai Lab has now obtained approvals for marketing ZEJULA in Mainland China, Hong Kong and Macau for maintenance therapy in patients with platinum-sensitive, recurrent ovarian cancer.

Since the Hong Kong launch of ZEJULA in October 2018, it has rapidly gained market share in the region despite being launched more than two years behind Lynparza. Based on IQVIA (formerly IMS) data, ZEJULA is now the market leading PARP inhibitor with market share in Hong Kong of 77% by value in the third quarter of 2019.

ZEJULA is also being evaluated in China in pivotal studies as first-line maintenance therapy in small-cell lung cancer.

IMPORTANT SAFETY INFORMATION

The most common side effects for patients taking ZEJULA include heart not beating regularly, nausea, constipation, vomiting, pain in the stomach area, mouth sores, diarrhea, indigestion or heartburn, dry mouth, tiredness, loss of appetite, urinary tract infection, shortness of breath, cough, rash, changes in liver function or other blood tests, pain in your joints, muscles, and back, headache, dizziness, change in the way food tastes, trouble sleeping, anxiety, sore throat and changes in the amount or color of your urine. Other potential serious side effects include bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML), symptoms of low blood cell counts (which can be a sign of serious bone marrow problems) and high blood pressures. Patients should take a few medical tests before they are treated with ZEJULA. Healthcare providers should periodically monitor their patients’ blood cell counts and blood pressures.

On December 27, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported that the first patient has been dosed in a phase 1b clinical study of MorphoSys’ proprietary human anti-CD19 antibody tafasitamab in newly diagnosed diffuse large B cell lymphoma (DLBCL) (Press release, MorphoSys, DEC 27, 2019, View Source [SID1234552617]). The phase 1b study is an open-label, randomized, multicenter study to evaluate safety and preliminary efficacy of tafasitamab in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristin, prednison) as well as tafasitamab and lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated DLBCL. Patients enrolled in each arm will receive six cycles of treatment. The primary endpoint is the incidence and severity of treatment-emergent adverse events (AEs), key secondary endpoints are objective response rate (ORR) and PET-negative complete response (CR) rate at the end of treatment.

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"It is a great opportunity for us to expand the clinical development of tafasitamab into firstline DLBCL," said Dr. Malte Peters, Chief Development Officer of MorphoSys. "Based on the encouraging results we have seen so far with tafasitamab in relapsed and refractory DLBCL, we are now looking forward to explore the potential of tafasitamab in addition to
R-CHOP or lenalidomide and R-CHOP in newly diagnosed DLBCL. This phase 1b study forms the basis for a subsequent pivotal phase 3 study in front line DLBCL. DLBCL is an aggressive and very challenging disease and we hope to improve the current R-CHOP standard of care by adding tafasitamab and lenalidomide to offer a potential new treatment option for these critically ill patients."

About tafasitamab (MOR208)
Tafasitamab (formerly MOR208) is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. Fc-modification of tafasitamab is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. Tafasitamab has been observed in preclinical models to induce direct apoptosis by binding to CD19, which is assumed to be involved in B cell receptor (BCR) signaling.
MorphoSys is clinically investigating tafasitamab as a therapeutic option in B cell malignancies in a number of ongoing combination trials. An open-label phase 2 combination trial (L-MIND study) is investigating the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population. B-MIND is a phase 3 study assessing the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. In addition, tafasitamab is currently being investigated in patients with relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.