On April 6, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that the first patient was dosed in a phase 2 combination trial of MOR208 with lenalidomide (Revlimid) (Press release, MorphoSys, APR 6, 2016, View Source [SID:1234510438]).

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The trial, which has been named L-MIND (Lenalidomide-MOR208 IN DLBCL), is designed to evaluate the safety and efficacy of MOR208 in combination with the immunomodulatory drug lenalidomide in adult subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma (NHL). MOR208 is a potent anti-CD19 antibody with a proprietary modification to the Fc portion, and is being developed to treat B cell malignancies.

The single-arm, open-label, multicenter L-MIND study is expected to enroll 80 patients in 56 centers in 9 European countries and the USA. At the time of study entry, patients must present with relapsed or refractory DLBCL, which had previously been treated with at least one and not more than two prior lines of therapy, including one anti-CD20 targeting therapy (e.g. rituximab). Patients must not be candidates for high-dose chemotherapy with autologous stem cell transplantation.

Patients will receive weekly intravenous infusions of 12mg/kg MOR208 for 12 weeks, followed by administration every second week for up to 2 years or until disease progression or unacceptable toxicity, whichever comes first. In addition to MOR208, lenalidomide will be administered orally, for up to one year.

The study’s primary end point is overall response rate (ORR), comprising complete responses (CR) and partial responses (PR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS), as well as an evaluation of the drug combination’s safety and pharmacokinetic parameters of MOR208.

"We are pleased to kick off the L-MIND trial as the first in a series of planned clinical studies evaluating combination therapies with MOR208 in hemato-oncological indications with high medical need. MOR208 has already demonstrated very encouraging single-agent activity and was well tolerated by patients in our phase 2a NHL trial as presented at the ASH (Free ASH Whitepaper) 2015 conference in December 2015. In addition, an ongoing Phase 2 investigator-initiated trial has already shown good preliminary safety and activity of the combination of MOR208 and lenalidomide in patients suffering from chronic lymphocytic leukemia (CLL). These recent findings encourage us to explore the therapeutic potential of MOR208 in different combinations", said Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

Detailed information on the trial can be found at clinicaltrials.gov.

About MOR208:
MOR208 is an Fc-enhanced antibody targeting CD19, a more widely and earlier expressed target across multiple lymphomas and leukemias than CD20, the therapeutic target of the most commonly used lymphoma and leukemia targeted treatments. MOR208 has been engineered to possess significantly enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), thus improving a key mechanism for tumor cell killing. By targeting CD19 and being Fc-enhanced, MOR208 could therefore become an important and attractive alternative to multiple current treatment options for some of the sickest cancer patients.

Updated interim data, presented at the 2015 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (ASH 2015) in December 2015, summarize efficacy and safety results for MOR208 monotherapy in 92 heavily pre-treated patients. The overall response rate was 28% across all four subtypes of non-Hodgkin’s lymphoma (NHL) and reached 36% in the diffuse large B cell lymphoma (DLBCL) subgroup (both based on evaluable patients). At the time of the analysis, several responders – 9 out of 21 – had an ongoing response to the single-agent treatment. The longest response duration observed so far exceeded 20 months in both DLBCL and follicular lymphoma (FL).

On April 6, 2016 AstraZeneca reported that it will report new clinical trial and scientific data from their industry-leading lung cancer franchise of marketed and pipeline medicines at the European Lung Cancer Conference (ELCC) together with its global biologics research and development arm, MedImmune, in Geneva, Switzerland, 13 -16 April, 2016 (Press release, AstraZeneca, APR 6, 2016, View Source [SID:1234510436]).

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Fifteen abstracts will be presented at the meeting including eight oral presentations, two "best abstracts" and two "late-breakers". Five abstracts have been selected for the official press programme. Highlights will reinforce the potential of Tagrisso (osimertinib) for the treatment of specific types of advanced non-small cell lung cancer (NSCLC), compare plasma testing and tumour tissue biopsy for treatment decisions in advanced NSCLC, and demonstrate the progress of combination therapy in immuno-oncology.

Tagrisso in first- and second-line lung cancer treatment

Two oral, late-breaker presentations share data from the Tagrisso AURA studies. They build on evidence that supported the accelerated approval of Tagrisso as the first indicated treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive metastatic NSCLC in the US, EU and Japan.

On Thursday 14 April, updated efficacy and safety data will be presented from two Phase I expansion cohorts exploring Tagrisso as first-line treatment for patients with EGFRm advanced NSCLC (Abstract #LBA1_PR). Phase I/II data in pre-treated patients with EGFR T790M advanced NSCLC (Abstract #LBA2_PR) will also be presented. Both presentations will feature in the ELCC press programme on Thursday 14 April.

Mondher Mahjoubi, Senior Vice President, Head of Oncology, Global Product and Portfolio Strategy at AstraZeneca, said: "ELCC’s recognition of the importance of our data for the lung cancer community is very encouraging and we are excited to present more mature data from the AURA programme for our new, first-in-class lung cancer medicine, Tagrisso. We are also reaffirming our commitment to deliver the right treatment to the right patient based on scientific research, with updates from our pioneering plasma circulating tumour DNA trials."

Plasma ctDNA testing: Delivering the right treatment to the right patient

Accurate identification of patients with tumours carrying key molecular mutations is essential for delivering next-generation targeted therapies to those most likely to benefit. Detection of plasma circulating tumour-derived DNA (ctDNA) in a simple blood test offers a minimally invasive alternative to tumour tissue biopsy, and is already available for identifying patients suitable for treatment with AstraZeneca’s Iressa.

Building on this work, the latest results from innovative research in minimally invasive plasma ctDNA analysis to identify patients with EGFRm T790M NSCLC and predict response to Tagrisso will be reported (Abstract #134O_PR and #135O_PR). Further data from the ASSESS study for EGFR mutation detection in plasma from this patient group will also be presented (Abstract #58O_PR). ASSESS is the first largescale "real-world" study comparing tumour biopsy with ctDNA testing for EGFRm in advanced NSCLC. These studies are highlighted in the ELCC press programme on Friday 15 April.

Marc Denis, Professor of Biochemistry and Molecular Biology at Nantes University Hospital, Nantes, France, said: "Plasma ctDNA testing has the potential to rapidly identify patients suitable for targeted therapy not just for lung cancer but across a wide range of tumour types. Availability of these simple blood tests may streamline diagnosis, including for patients where tumour samples are unavailable."

Immuno-oncology (IO): Combination focus

AstraZeneca has a broad programme of combination clinical trials underway in oncology and continues to explore novel combination therapies addressing the needs of difficult-to-treat patients with lung cancer. Safety and efficacy data from two exploratory trials combining immunotherapies and small-molecules will be reported at ELCC. These presentations have been designated "best abstracts" (Abstracts #57O and #136O) by the conference.

Robert Iannone, Head of Immuno-Oncology, Global Medicines Development, at AstraZeneca, said: "Durvalumab is the cornerstone of our IO portfolio and we have a rapidly-advancing development programme focused primarily on novel combinations. At ELCC, we are presenting the exceptional science behind our combination approach with abstracts describing the ongoing MYSTIC and NEPTUNE studies combining durvalumab with tremelimumab. These build on recent data showing the anti-tumour activity of this combination in patients with metastatic NSCLC irrespective of PD-L1 status, as published in The Lancet Oncology."