Drug approval and progress for GSK

Company reports FDA approval of its HIV regimen, Dovato, and positive data from a Phase 3 multiple myeloma study

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LONDON—GlaxoSmithKline (GSK) has had some good news to share recently, with both an U.S. Food and Drug Administration (FDA) approval for an human immunodeficiency virus (HIV) therapy and positive Phase 3 data for a multiple myeloma treatment.
GSK has to share the joy with the approval, as the news comes out of ViiV Healthcare, a global specialist HIV company established in November 2009 by GSK and Pfizer to advance treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV (Shionogi joined as a shareholder in October 2012). But to get to the point, what ViiV reported on April 8 was that the FDA had approved Dovato—a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg—for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC.
According to ViiV, the Dovato two-drug regimen reduces exposure to the number of ARVs from the start of treatment, while still maintaining the efficacy and high barrier to resistance of a traditional DTG-based three-drug regimen.
“Building on our innovative portfolio of medicines, Dovato is powered by dolutegravir, an antiretroviral included in multiple combination therapies and the most prescribed integrase inhibitor in the world, coupled with the established profile of lamivudine,” said Deborah Waterhouse, CEO of ViiV Healthcare. “With Dovato, the first complete, single-tablet, two-drug regimen for treatment-naïve adults, ViiV Healthcare is delivering what patients are requesting—a chance to treat their HIV-1 infection with as few drugs as possible, marking a significant step in HIV treatment.”
The approval of Dovato was supported by the global GEMINI 1 and 2 studies, which included more than 1,400 HIV-1 infected adults. In these studies, DTG + 3TC demonstrated non-inferiority based on plasma HIV-1 RNA <50 copies per milliliter (c/mL), a standard measure of HIV-1 control, at Week 48 when compared to a three-drug regimen of DTG and two nucleoside reverse transcriptase inhibitors (NRTIs)—tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)—in treatment-naïve, HIV-1 infected adults. The safety results for DTG + 3TC seen in GEMINI 1 and 2 were consistent with the product labelling for DTG and 3TC. No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance.
Said Pedro Cahn, principal investigator for the GEMINI study program: “People are now living longer with HIV and will spend a lifetime taking drugs to suppress their virus. The approval of the fixed-dose combination of dolutegravir and lamivudine—a complete, single-tablet, two-drug regimen—marks a pivotal moment in the treatment of HIV-1. Treatment-naïve people living with the virus have a powerful option that delivers non-inferior efficacy to a dolutegravir-based three-drug regimen, allowing them to take fewer ARVs and get and remain suppressed.”
And now ViiV looks beyond the U.S. borders as well for more good news, noting that DTG/3TC as a complete, once-daily, single-tablet, two-drug regimen for HIV-1 therapy is currently under review by the European Medicines Agency (EMA) and regulatory authorities in Canada, Australia, Switzerland and South Africa. Several additional submissions are planned throughout 2019.
In the other recent news, this bit from late March, GSK gets to keep all the joy to itself with word of further positive data from the DREAMM-1 study of patients with relapsed/refractory multiple myeloma who received GSK2857916, an investigational anti-B cell maturation antigen (BCMA) antibody-drug conjugate. These results, published in Blood Cancer Journal, build upon results from the pre-specified interim analysis, which were first presented at the American Society of Haematology Congress in 2017.
These new data confirm that 60 percent of patients receiving GSK2857916 achieved an overall response rate (ORR). This ORR was identical to the rate previously reported in the interim analysis, after more than a year of follow-up, and demonstrates not only the potential efficacy of the medicine but the durability and depth of response. The number of patients achieving a complete response increased to 15 percent over this additional one year follow-up period. The median progression-free survival (PFS) was 12 months, an increase from the previously reported 7.9 months PFS. The median duration of response in the final analysis was 14.3 months. All patients whose data were reported in the interim analysis were included in this analysis.
“These data are very encouraging, and I am excited by what they could mean for people living with multiple myeloma,” commented Dr. Hal Barron, chief scientific officer and president of R&D at GSK. “We are aggressively advancing this potential new medicine and plan to have pivotal data to support its filing by the end of this year.”
A total of 35 patients were enrolled in Part 2 of the DREAMM-1 study independent of their BCMA expression levels. No new safety signals were identified during this treatment period. The most commonly reported adverse events were thrombocytopenia, blurred vision and cough, all of which were mostly mild or moderate (Grade 1 or 2). The most commonly reported Grade 3 or 4 adverse events were thrombocytopenia and anemia, and these “were found to be manageable,” according to GSK.
Paul Giusti, president and CEO of the Multiple Myeloma Research Foundation (MMRF), remarked, “Significant advancements have been made in our knowledge, understanding and the treatment of multiple myeloma in the past decade, but there is so much more that we as a community need to do to accelerate better outcomes and quality of life for patients. Relapses are particularly challenging, so the need for treatment advances is a priority at the MMRF to ensure our patients can benefit from them in the future. We are encouraged by the results from this early study, and we look forward to seeing additional data later this year.”
In 2017, GSK2857916 was awarded Breakthrough Therapy designation from the FDA and PRIME designation from the EMA.

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