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AbbVie's Brain Cancer Candidate Fails in Phase III Study
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AbbVie, Inc. (ABBV - Free Report) announced that a late-stage study evaluating its pipeline candidate, depatuxizumab mafodotin (Depatux-M) failed to show any survival benefit in patients with newly diagnosed glioblastoma, an aggressive form of brain cancer.
The phase III INTELLANCE-1 study, conducted in collaboration with the RTOG Foundation, did not meet the primary endpoint of overall survival at the interim analysis. The Independent Data Monitoring Committee (IDMC) recommended that the study be stopped due to lack of survival benefit in patients treated with Depatux-M compared with placebo when added to the standard regimen of radiation and temozolomide. Enrolment has been stopped in all ongoing Depatux-M studies.
AbbVie’s stock has declined 13.8% this year so far compared with a decrease of 1.1% recorded by the industry.
Oncology is a key therapeutic area for AbbVie and the company believes that it will be its major growth driver over the next 10 years. Key drugs in its oncology portfolio are Imbruvica, currently approved for quite a few indications and marketed in partnership with J&J (JNJ - Free Report) , and Venclyxto/Venclexta, approved to treat chronic lymphocytic leukemia (CLL) and marketed in partnership with Roche (RHHBY - Free Report) .
Several studies on Imbruvica are ongoing to evaluate the drug alone or in combination in different patient segments.AbbVie is also studying Venclyxto/Venclexta to expand the label to address the broader relapsed/refractory CLL patient population, expand into earlier lines of therapy, and broaden into other hematologic malignancies like multiple myeloma and acute myeloid leukemia (AML).
Despite the presence of successful medicines in its portfolio, AbbVie has had its shares of failure in cancer studies. In March, the FDA placed a partial clinical hold on all studies evaluating Venclexta for the treatment of multiple myeloma. The decision was taken after a higher proportion of deaths was observed in the Venclexta arm compared to the control arm of the study in the ongoing phase III BELLINI study,
Last year, AbbVie’s rovalpituzumab tesirine or Rova-T fell short of expectations in a phase II TRINITY study evaluating it in third-line or later small cell lung cancer (SCLC). Rova-T was added to AbbVie’s portfolio following the $5.8 billion acquisition of Stemcentrx in June 2016.
AbbVie said it will not seek accelerated approval of Rova-T in the third-line setting after consulting with the FDA. In December, AbbVie stopped enrolment in a pivotal phase III study — TAHOE — evaluating Rova-T in second-line small cell lung cancer (SCLC). The failure of TRINITY and the halt on TAHOE have raised skepticism on Rova-T’s potential and brought into question the viability of the Stemcentrx deal.
Shares of Merck have gained 3% so far this year while estimates for 2019 and 2020 have risen 1.5% and 0.8%, respectively, over the past 30 days.
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AbbVie's Brain Cancer Candidate Fails in Phase III Study
AbbVie, Inc. (ABBV - Free Report) announced that a late-stage study evaluating its pipeline candidate, depatuxizumab mafodotin (Depatux-M) failed to show any survival benefit in patients with newly diagnosed glioblastoma, an aggressive form of brain cancer.
The phase III INTELLANCE-1 study, conducted in collaboration with the RTOG Foundation, did not meet the primary endpoint of overall survival at the interim analysis. The Independent Data Monitoring Committee (IDMC) recommended that the study be stopped due to lack of survival benefit in patients treated with Depatux-M compared with placebo when added to the standard regimen of radiation and temozolomide. Enrolment has been stopped in all ongoing Depatux-M studies.
AbbVie’s stock has declined 13.8% this year so far compared with a decrease of 1.1% recorded by the industry.
Oncology is a key therapeutic area for AbbVie and the company believes that it will be its major growth driver over the next 10 years. Key drugs in its oncology portfolio are Imbruvica, currently approved for quite a few indications and marketed in partnership with J&J (JNJ - Free Report) , and Venclyxto/Venclexta, approved to treat chronic lymphocytic leukemia (CLL) and marketed in partnership with Roche (RHHBY - Free Report) .
Several studies on Imbruvica are ongoing to evaluate the drug alone or in combination in different patient segments.AbbVie is also studying Venclyxto/Venclexta to expand the label to address the broader relapsed/refractory CLL patient population, expand into earlier lines of therapy, and broaden into other hematologic malignancies like multiple myeloma and acute myeloid leukemia (AML).
Despite the presence of successful medicines in its portfolio, AbbVie has had its shares of failure in cancer studies. In March, the FDA placed a partial clinical hold on all studies evaluating Venclexta for the treatment of multiple myeloma. The decision was taken after a higher proportion of deaths was observed in the Venclexta arm compared to the control arm of the study in the ongoing phase III BELLINI study,
Last year, AbbVie’s rovalpituzumab tesirine or Rova-T fell short of expectations in a phase II TRINITY study evaluating it in third-line or later small cell lung cancer (SCLC). Rova-T was added to AbbVie’s portfolio following the $5.8 billion acquisition of Stemcentrx in June 2016.
AbbVie said it will not seek accelerated approval of Rova-T in the third-line setting after consulting with the FDA. In December, AbbVie stopped enrolment in a pivotal phase III study — TAHOE — evaluating Rova-T in second-line small cell lung cancer (SCLC). The failure of TRINITY and the halt on TAHOE have raised skepticism on Rova-T’s potential and brought into question the viability of the Stemcentrx deal.
AbbVie currently carries a Zacks Rank #2 (Buy).
Another top-ranked large-cap pharma stock is Merck & Co., Inc. (MRK - Free Report) , which has a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Shares of Merck have gained 3% so far this year while estimates for 2019 and 2020 have risen 1.5% and 0.8%, respectively, over the past 30 days.
This Could Be the Fastest Way to Grow Wealth in 2019
Research indicates one sector is poised to deliver a crop of the best-performing stocks you'll find anywhere in the market. Breaking news in this space frequently creates quick double- and triple-digit profit opportunities.
These companies are changing the world – and owning their stocks could transform your portfolio in 2019 and beyond. Recent trades from this sector have generated +98%, +119% and +164% gains in as little as 1 month.
Click here to see these breakthrough stocks now >>