On March 16, 2015 Janssen Research & Development, LLC (Janssen) reported that a pre-planned interim analysis of the Phase 3 HELIOS (CLL3001) study investigating the combination of IMBRUVICA (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), showed the trial has met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) (Press release, Johnson & Johnson, MAR 16, 2015, View Source [SID:1234502293]). An Independent Data Monitoring Committee (IDMC) recommends that the study be unblinded and patients receiving placebo plus BR should be offered the option to receive IMBRUVICA as their next treatment. IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics, Inc.

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"This is the second randomized, controlled study in patients with previously treated CLL or SLL to show a significant improvement in progression-free survival, further underscoring the potential of IMBRUVICA," said Sen Zhuang, M.D., Ph.D., Vice President, Oncology Clinical Research, Janssen. "The data from the Phase 3 RESONATE trial demonstrated that IMBRUVICA as a single agent significantly improved both progression-free and overall survival compared to ofatumumab. Now, the interim data from HELIOS demonstrate that IMBRUVICA may be incorporated into a regimen with bendamustine and rituximab to improve outcomes for patients."

HELIOS is a Janssen-sponsored, randomized, double-blind, placebo-controlled, international, multicenter Phase 3 study conducted in 21 countries, which evaluated the safety and efficacy of IMBRUVICA in combination with BR in 578 patients with relapsed or refractory CLL/SLL who had received at least one prior therapy. Patients were randomized to receive either the combination of 420 mg IMBRUVICA orally once daily and six cycles of BR, or a matching regimen of placebo orally once daily and six cycles of BR, with IMBRUVICA or placebo continued until disease progression or unacceptable toxicity.

The primary endpoint of the HELIOS study is PFS, with secondary endpoints including safety (adverse events), overall response rate (ORR), overall survival (OS), rate of minimal residual disease (MRD)-negative responses and other improvements in hematologic values, disease-related symptoms and patient-reported outcome scores.

These topline results are planned to be submitted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, as well as for publication in a peer-reviewed journal. A full study report is being prepared and planned to be submitted to health authorities for future labeling considerations.

On March 16, 2015 Genmab reported it has decided not to exercise the co-development right for HuMax-TAC-ADC under its agreement with ADC Therapeutics Sarl. Genmab will retain 25% of the rights to the product (Press release, Genmab, MAR 16, 2015, View Source [SID:1234502292]). Under the terms of the companies’ agreement, Genmab had a 50% ownership stake with an option to maintain equal ownership of HuMax-TAC-ADC prior to the submission of an Investigational New Drug (IND) application and fund half of the development costs. Genmab has decided not to maintain its co-development right for HuMax-TAC-ADC, but will retain a 25% ownership stake in the product. ADC Therapeutics has indicated it intends to file an IND for HuMax-TAC-ADC in the first half of 2015.

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"While we have decided not to fund co-development of HuMax-TAC-ADC with ADC Therapeutics, we are pleased to still have 25% of the rights to the product, which has potential to become a first-in-class antibody-drug conjugate therapeutic in certain hematological cancer indications," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About HuMax-TAC-ADC
HuMax-TAC-ADC is an ADC combining Genmab’s HuMax-TAC antibody and ADC Therapeutics’ PBD-based warhead and linker technology. HuMax-TAC-ADC targets CD25, which is expressed on a variety of hematological tumors and shows limited expression on normal tissues, which makes it a very attractive target for antibody-payload approaches. HuMax-TAC-ADC has the potential to be a first-in-class antibody-drug conjugate for the treatment of CD25-expressing lymphomas and leukemias. HuMax-TAC-ADC is in development under an agreement between Genmab and ADC Therapeutics.

About PBD Warheads & Linkers
ADCs developed using ADC Therapeutics’ technology combine monoclonal antibodies specific to particular tumor targets with highly potent pyrrolobenzodiazepine (PBD) based warheads developed by ADC Therapeutic’s partner Spirogen Limited. These PBD warheads are joined to antibodies by linkers that release the PBD warhead in the targeted cancer cells. This technology has attracted the attention of other biotechnology companies such as Genentech and Seattle Genetics.