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AbbVie (ABBV) Starts Late-Stage Study on Multiple Myeloma Drug
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AbbVie (ABBV - Free Report) dosed the first patient with ABBV-383, an investigational BCMA-CD3-targeted bispecific antibody, in the phase III CERVINO study to treat relapsed/refractory (r/r) multiple myeloma (MM).
The CERVINO study will enroll nearly 380 patients with r/r MM who have received at least two lines of prior therapy. Patients will be randomized into two equal groups — either to receive a 60mg dose of intravenously-administered ABBV-383 once every four weeks or the investigator's choice of standard available therapies (SAT).
Per AbbVie, the study investigator can offer one of the three SATs — one involving Amgen’s Kyprolis plus dexamethasone, another involving Bristol Myers’ cancer drugs Empliciti and Pomalyst plus dexamethasone, or a third one involving Karyopharm Therapeutics’ Xpovio plus bortezomib and dexamethasone. Each of these combination therapies has already been approved by the FDA to treat r/r MM.
The dual primary endpoints of the CERVINO study are progression-free survival (PFS) and objective response rate (ORR).
Per AbbVie, MM is the second most commonly-occurring blood cancer in the world. Management estimates that around 176,000 people globally were diagnosed with MM in 2020.
AbbVie’s shares have gained 6.8% in the year compared with the industry’s 18.5% growth.
Image Source: Zacks Investment Research
AbbVie’s efforts to strengthen its oncology/hematology sales are also showing promise. In February, management completed the acquisition of ImmunoGen, following which it added ovarian cancer drug Elahere to its portfolio. AbbVie is also marketing the recently approved lymphoma drug Epkinly/Tepkinly in partnership with Genmab, whose sales have also started to pick up pace.
Management also intends to strengthen its oncology pipeline. In this regard, it entered into agreements with companies like Umoja Biopharma and Tentarix Biotherapeutics to explore different modalities, like cell therapy and multi-functional biologics, to identify new treatment approaches.
If CERVINO study results are positive and the FDA potentially approves the drug, AbbVie will likely compete with Johnson & Johnson (JNJ - Free Report) and Pfizer (PFE - Free Report) , both of which are currently marketing their respective MM drugs that utilize a mechanism similar to ABBV-383.
J&J currently markets Tecvayli, a BCMA-CD3-targeted bispecific antibody that is approved to treat patients with r/r MM who have received at least four prior lines of therapy. However, the J&J drug initially requires a step-up dosing schedule, and patients are subsequently moved to weekly dosing and, if certain conditions are satisfied, even biweekly dosing. Apart from Tecvayli, J&J also markets other MM therapies, namely CAR-T cell therapy Carvykti and GPRC5D- CD3-targeted antibody Talvey.
Last year, the FDA approved Pfizer’s Elrexfio, also a BCMA-CD3-targeted bispecific antibody, to treat r/r MM patients who have received at least four prior lines of therapy. Like Tecvayli, Pfizer’s drug also requires step-up dosing, and patients are subsequently moved to weekly dosing and even biweekly dosing if they meet certain criteria.
In the past 60 days, estimates for Arcutis Biotherapeutics’ 2024 loss per share have narrowed from $2.49 to $1.60. During the same period, the loss estimates per share for 2025 have improved from $1.77 to $1.14. Year to date, shares of Arcutis have surged 146.8%.
Earnings of Arcutis Biotherapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. Arcutis delivered a four-quarter average earnings surprise of 14.93%.
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AbbVie (ABBV) Starts Late-Stage Study on Multiple Myeloma Drug
AbbVie (ABBV - Free Report) dosed the first patient with ABBV-383, an investigational BCMA-CD3-targeted bispecific antibody, in the phase III CERVINO study to treat relapsed/refractory (r/r) multiple myeloma (MM).
The CERVINO study will enroll nearly 380 patients with r/r MM who have received at least two lines of prior therapy. Patients will be randomized into two equal groups — either to receive a 60mg dose of intravenously-administered ABBV-383 once every four weeks or the investigator's choice of standard available therapies (SAT).
Per AbbVie, the study investigator can offer one of the three SATs — one involving Amgen’s Kyprolis plus dexamethasone, another involving Bristol Myers’ cancer drugs Empliciti and Pomalyst plus dexamethasone, or a third one involving Karyopharm Therapeutics’ Xpovio plus bortezomib and dexamethasone. Each of these combination therapies has already been approved by the FDA to treat r/r MM.
The dual primary endpoints of the CERVINO study are progression-free survival (PFS) and objective response rate (ORR).
Per AbbVie, MM is the second most commonly-occurring blood cancer in the world. Management estimates that around 176,000 people globally were diagnosed with MM in 2020.
AbbVie’s shares have gained 6.8% in the year compared with the industry’s 18.5% growth.
Image Source: Zacks Investment Research
AbbVie’s efforts to strengthen its oncology/hematology sales are also showing promise. In February, management completed the acquisition of ImmunoGen, following which it added ovarian cancer drug Elahere to its portfolio. AbbVie is also marketing the recently approved lymphoma drug Epkinly/Tepkinly in partnership with Genmab, whose sales have also started to pick up pace.
Management also intends to strengthen its oncology pipeline. In this regard, it entered into agreements with companies like Umoja Biopharma and Tentarix Biotherapeutics to explore different modalities, like cell therapy and multi-functional biologics, to identify new treatment approaches.
If CERVINO study results are positive and the FDA potentially approves the drug, AbbVie will likely compete with Johnson & Johnson (JNJ - Free Report) and Pfizer (PFE - Free Report) , both of which are currently marketing their respective MM drugs that utilize a mechanism similar to ABBV-383.
J&J currently markets Tecvayli, a BCMA-CD3-targeted bispecific antibody that is approved to treat patients with r/r MM who have received at least four prior lines of therapy. However, the J&J drug initially requires a step-up dosing schedule, and patients are subsequently moved to weekly dosing and, if certain conditions are satisfied, even biweekly dosing. Apart from Tecvayli, J&J also markets other MM therapies, namely CAR-T cell therapy Carvykti and GPRC5D- CD3-targeted antibody Talvey.
Last year, the FDA approved Pfizer’s Elrexfio, also a BCMA-CD3-targeted bispecific antibody, to treat r/r MM patients who have received at least four prior lines of therapy. Like Tecvayli, Pfizer’s drug also requires step-up dosing, and patients are subsequently moved to weekly dosing and even biweekly dosing if they meet certain criteria.
AbbVie Inc. Price
AbbVie Inc. price | AbbVie Inc. Quote
Zacks Rank & Key Pick
AbbVie currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Arcutis Biotherapeutics (ARQT - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Arcutis Biotherapeutics’ 2024 loss per share have narrowed from $2.49 to $1.60. During the same period, the loss estimates per share for 2025 have improved from $1.77 to $1.14. Year to date, shares of Arcutis have surged 146.8%.
Earnings of Arcutis Biotherapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. Arcutis delivered a four-quarter average earnings surprise of 14.93%.