BMS Signs Cancer Pacts with Novartis, Qiagen, and Seattle GeneticsBy
Bristol-Myers Squibb has formed separate research pacts with Novartis, Qiagen, and Seattle Genetics for oncology.
In the first deal, Bristol-Myers Squibb has entered into a clinical research collaboration with Novartis to investigate the safety, tolerability, and efficacy of Bristol-Myers Squibb’s Opdivo (nivolumab) and Bristol-Myers Squibb’s Opdivo + Yervoy (ipilimumab) regimen in combination with Novartis’ Mekinist (trametinib), as a potential treatment option for metastatic colorectal cancer in patients with microsatellite stable tumors where the tumors are proficient in mismatch repair.
The Phase I/II study is expected to establish recommended dose regimens and explore the preliminary anti-tumor activity of combining trametinib with Opdivo as well as trametinib in combination with the Opdivo + Yervoy regimen. Results will be used to determine optimal approaches to further potential clinical development of these combinations.
Opdivo is Bristol-Myers Squibb’s immuno-oncology drug with 2016 sales of $3.77 billion and is approved for multiple cancer indications.. In the US, Opdivo is indicated for treating BRAF V600 mutation-positive unresectable or metastatic melanoma and BRAF V600 wild-type unresectable or metastatic melanoma as a single agent; unresectable or metastatic melanoma in combination with Yervoy (ipilimumab); metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; and locally advanced or metastatic urothelial carcinoma.
In a second deal, Bristol-Myers Squibb has formed an agreement with Qiagen, a diagnostic company, to explore the use of next-generation sequencing (NGS) technology to develop gene expression profiles (GEPs) as predictive or prognostic tools for use with Bristol-Myers Squibb immuno-oncology (I-O) therapies in cancer treatment. This will leverage the combination of Bristol-Myers Squibb’s portfolio of I-O therapies with Qiagen’s expertise in developing and commercializing companion and complementary diagnostics as well as Qiagen’s portfolio of NGS technologies. I-O therapies offer a novel way to treat cancer by using drugs to target the body’s immune system to help fight cancer.
Qiagen and Bristol-Myers Squibb intend to develop GEPs for several Bristol-Myers Squibb I-O molecules under the initial agreement. The companies also plan to enter into a further agreement to develop diagnostic products using the jointly developed GEPs and to expand the use of NGS technology with other Bristol-Myers Squibb I-O therapies.
Qiagen and Bristol-Myers Squibb have been partnering since 2009. A key milestone in this partnership was the FDA approval of the Therascreen KRAS companion/complementary diagnostic assay in 2012.
In the third deal, Bristol-Myers Squibb and Seattle Genetics have entered into a collaboration agreement to evaluate the combination of Bristol-Myers Squibb’s immunotherapy Opdivo and Seattle Genetics’ antibody-drug conjugate, Adcetris (brentuximab vedotin) in a Phase III clinical trial. The trial will evaluate the combination of Adcetris and Opdivo versus Adcetris alone as a potential treatment option for patients with relapsed/refractory or transplant-ineligible advanced classical Hodgkin lymphoma (HL). The study is expected to begin in mid-2017.
In addition to the planned trial, Adcetris and Opdivo are being evaluated as combination therapy in multiple ongoing Phase I/II clinical trials. These include studies in patients with relapsed or refractory Hodgkin lymphoma and CD30-expressing relapsed or refractory non-Hodgkin lymphomas, including T-cell lymphomas, diffuse large B-cell lymphoma, and other rare subtypes of B-cell malignancies, including mediastinal B-cell lymphoma and mediastinal gray zone lymphoma. In addition, the Adcetris and Opdivo combination is being evaluated for older HL patients and relapsed/refractory classical HL for children, adolescents and young adults.