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Roche (RHHBY) Presents Positive Data on Venclexta at EHA 2020
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Roche (RHHBY - Free Report) announced positive results from a late-stage study on Venclexta in the 25th European Hematology Association (“EHA”) Virtual Congress Press Briefing.
The phase III study was evaluating Venclexta/Venclyxto in combination with Vidaza in patients with previously untreated acute myeloid leukemia (“AML”) who were ineligible for intensive induction chemotherapy.
Results from the VIALE-A study showed that the combination reduced the risk of death by 34% compared with Vidaza alone in patients. The combination also led to higher rates of composite complete remission.
Notably, the FDA has already granted accelerated approval to Venclexta in combination with Vidaza or decitabine or low-dose cytarabine for the treatment of newly diagnosed AML in patients aged 75 years or older or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. Continued approval for the indication may be contingent upon verification and description of clinical benefit in confirmatory studies.
VIALE-A is part of Venclexta’s ongoing development program to convert the current accelerated approval in previously untreated AML to full approval. It is being developed by AbbVie (ABBV - Free Report) and Roche. While AbbVie commercializes it in the United States, it is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the United States.
Separately, Roche announced updated data on one of its investigational CD20xCD3 T-cell engaging bispecific antibodies, glofitamab (formerly known as CD20-TCB), in patients suffering from relapsed or refractory (R/R) non-Heodgkin lymphoma (“NHL”). Results of the phase I NP30179 study showed durable complete responses with glofitamab in patients with aggressive and indolent lymphomas after a median of three prior lines of therapy.
Roche is evaluating the candidate in a broad program either alone or in combination with other drugs.
The company also presented two-year data from part 1 of the SUNFISH study in people aged 2-25 years with type 2 or 3 spinal muscular atrophy (“SMA”) at the virtual Cure SMA Annual Conference. SMA is a severe, inherited, progressive neuromuscular disease. Results showed that risdiplam significantly improved motor function after 24 months of treatment compared with natural history data.
Additionally, preliminary 12-month data from JEWELFISH study in SMA patients aging 6 months to 60 years, who were previously treated with other SMA therapies, showed that treatment with risdiplam led to rapid and sustained increases in SMN protein levels.
Safety in both studies was consistent with the safety profile observed to date and no new safety signals were identified.
We note that the FDA granted Priority Review to risdiplam, with an expected decision on approval by Aug 24, 2020.
Roche’s efforts to develop its portfolio are encouraging as its legacy drugs face stiff biosimilar competition. Strong growth in Ocrevus, Perjeta, Tecentriq and Hemlibra countered biosimilar competition for Herceptin and MabThera from the likes of Amgen (AMGN - Free Report) and Allergan.
The company was in news recently due to its efforts to develop diagnostics tests and treatments for COVID-19. Roche also initiated a late-stage study on Actemra/RoActemra in combination with Gilead Sciences’ (GILD - Free Report) remdesivir in hospitalized patients with severe COVID-19 pneumonia.
Roche’s stock has gained 7.2% in the year so far against the industry’s decline of 3.4%.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
Image: Bigstock
Roche (RHHBY) Presents Positive Data on Venclexta at EHA 2020
Roche (RHHBY - Free Report) announced positive results from a late-stage study on Venclexta in the 25th European Hematology Association (“EHA”) Virtual Congress Press Briefing.
The phase III study was evaluating Venclexta/Venclyxto in combination with Vidaza in patients with previously untreated acute myeloid leukemia (“AML”) who were ineligible for intensive induction chemotherapy.
Results from the VIALE-A study showed that the combination reduced the risk of death by 34% compared with Vidaza alone in patients. The combination also led to higher rates of composite complete remission.
Notably, the FDA has already granted accelerated approval to Venclexta in combination with Vidaza or decitabine or low-dose cytarabine for the treatment of newly diagnosed AML in patients aged 75 years or older or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. Continued approval for the indication may be contingent upon verification and description of clinical benefit in confirmatory studies.
VIALE-A is part of Venclexta’s ongoing development program to convert the current accelerated approval in previously untreated AML to full approval. It is being developed by AbbVie (ABBV - Free Report) and Roche. While AbbVie commercializes it in the United States, it is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the United States.
Separately, Roche announced updated data on one of its investigational CD20xCD3 T-cell engaging bispecific antibodies, glofitamab (formerly known as CD20-TCB), in patients suffering from relapsed or refractory (R/R) non-Heodgkin lymphoma (“NHL”). Results of the phase I NP30179 study showed durable complete responses with glofitamab in patients with aggressive and indolent lymphomas after a median of three prior lines of therapy.
Roche is evaluating the candidate in a broad program either alone or in combination with other drugs.
The company also presented two-year data from part 1 of the SUNFISH study in people aged 2-25 years with type 2 or 3 spinal muscular atrophy (“SMA”) at the virtual Cure SMA Annual Conference. SMA is a severe, inherited, progressive neuromuscular disease. Results showed that risdiplam significantly improved motor function after 24 months of treatment compared with natural history data.
Additionally, preliminary 12-month data from JEWELFISH study in SMA patients aging 6 months to 60 years, who were previously treated with other SMA therapies, showed that treatment with risdiplam led to rapid and sustained increases in SMN protein levels.
Safety in both studies was consistent with the safety profile observed to date and no new safety signals were identified.
We note that the FDA granted Priority Review to risdiplam, with an expected decision on approval by Aug 24, 2020.
Roche’s efforts to develop its portfolio are encouraging as its legacy drugs face stiff biosimilar competition. Strong growth in Ocrevus, Perjeta, Tecentriq and Hemlibra countered biosimilar competition for Herceptin and MabThera from the likes of Amgen (AMGN - Free Report) and Allergan.
The company was in news recently due to its efforts to develop diagnostics tests and treatments for COVID-19. Roche also initiated a late-stage study on Actemra/RoActemra in combination with Gilead Sciences’ (GILD - Free Report) remdesivir in hospitalized patients with severe COVID-19 pneumonia.
Roche’s stock has gained 7.2% in the year so far against the industry’s decline of 3.4%.
The company currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
Click here for the 6 trades >>