Janssen Research & Development, Genentech Forge Clinical Trials Agreement

Published: Mar 23, 2016

Janssen Research & Development, Genentech Forge Clinical Trials Agreement
March 22, 2016 (Updated 12:20pm PT)
By Alex Keown, BioSpace.com Breaking News Staff

RARITAN, N.J. – Janssen Research & Development struck a deal with Genentech to initiate two studies to determine the safety and tolerability of daratumumab (Darzalex) and atezolizumab for treatment of in multiple myeloma and in solid tumor.

Genentech’s atezolizumab, an investigational monoclonal antibody designed to interfere with a protein called PD-L1 (Programmed Death Ligand-1), has shown clinical trial success in shrinking tumors in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed PD-L1.

Janssen’s Darzalex, the first CD38-directed monoclonal antibody (mAb), was licensed from Danish-based Genmab A/S . The two companies entered into an agreement in 2012, which gave Janssen the right to develop, manufacture and commercialize Darzalex.

Janssen said it will sponsor a Phase Ib, open-label, multicenter study that will investigate the potential of daratumumab in combination with atezolizumab in patients with solid tumor. This will be the first time Darzalex has been explored for use in solid tumors, Peter Lebowitz, global head of oncology at Janssen said in a statement. “…we look forward to better understanding how combining these two immunotherapies may potentially benefit patients with multiple myeloma and solid tumor, who are urgently in need of new options,” Lebowitz said.

The U.S. Food and Drug Administration approved Darzalex in 2015 for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. Darzalex is the first human CD38 monoclonal antibody approved anywhere in the world and the first therapeutic antibody ever approved to treat multiple myeloma. There is heavy competition in the multiple myeloma market, including Amgen ’s Kyprolis. But, since its approval, Darzalex has been reportedly well received by patients who are showing strong response to the medication. That strong response is opening doors for exploring its use for other cancer treatments.

Genentech will sponsor a Phase Ib, open-label, multicenter study that will be amended to assess atezolizumab in combination with daratumumab, with daratumumab and lenalidomide, and with daratumumab and pomalidomide in patients with relapsed or refractory multiple myeloma. Both trials are expected to begin dosing patients later this year.

In addition to the combination with Darzalex, Genentech’s atezolizumab is under trial for treating several types of cancer, including lung cancer and bladder cancer. This week the FDA granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma. Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra. In 2015, Atezolizumab was granted breakthrough therapy status by the FDA. In addition to lung and bladder cancer, atezolizumab is also showing promise in treating breast cancer.

In addition to its deal with Janssen, Genentech has also struck others for atezolizumab. In June 2015 Amgen (AMGN) announced a collaboration with Roche on a Phase Ib clinical trial to evaluate talimogene laherparepvec combined with atezolizumab (MPDL3280A) for the treatment of triple-negative breast cancer and colorectal cancer with liver metastases. Genentech and Clovis struck a deal to test a lung cancer dual combo therapy that utilizes Clovis’ investigational oral medication rociletinib and Genentech’s investigational injectable atezolizumab. Atezolizumab is being paired with Immune Design’s experimental cancer immunotherapy, CMB-305. The combination drug will be tested in a Phase II trial in patients with soft tissue sarcoma.

Most recently Kite Pharma struck a deal with Genentech to evaluate its experimental KTE-C19 with atezolizumab in patients with refractory, aggressive non-Hodgkin lymphoma (NHL). KTE-C19 is an investigational immunotherapy in which a patient's T cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias, Kite said last week when the company announced its deal with Genentech.

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