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EMA Committee Endorses AbbVie's Elahere in Ovarian Cancer
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AbbVie (ABBV - Free Report) announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking approval for its ovarian cancer drug Elahere (mirvetuximab soravtansine) in the EU.
AbbVie’s filing seeks marketing authorization for Elahere to treat adult patients with FRα-positive, platinum-resistant and high-grade serious epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatments.
This recommendation is based on data from data from the phase III MIRASOL study, which evaluated ABBV’s drug against the investor’s choice of single-agent chemotherapy in the given patient population. The study achieved its primary endpoint — treatment with Elaherereduced the risk of tumor progression or death by 35% compared with chemotherapy.
The CHMP’s recommendation will now be reviewed by the European Commission (EC) and a final decision is expected later this year. Though the EC generally follows the CHMP recommendation, it is not bound to do so. If approved, this will be the first regulatory approval for Elahere in the EU.
ABBV Stock Performance
Year to date, AbbVie’s shares have moved up 24.9% compared with the industry’s 23.5% rise.
Image Source: Zacks Investment Research
Recent Developments Related to ABBV’s Elahere
Elahere was recently granted full approval by the FDA for a similar indication, also supported by data from the MIRASOL study. The drug was initially approved for this indication under the accelerated pathway in 2022.
A first-in-class antibody-drug conjugate (ADC), Elahere, was added to AbbVie’s portfolio earlier this year in February following the acquisition of ImmunoGen for $10.1 billion. The drug is also being evaluated in multiple studies, both as monotherapy and in combination with other drugs, for ovarian cancer, which is likely to expand its use in earlier lines of therapy and additional patient populations.
In June, AbbVie reported positive results from the phase II PICCOLO study, which evaluated Elahere in heavily pre-treated patients with FRα-positive platinum-sensitive ovarian cancer (PSOC). The study achieved its primary endpoint — patients treated with Elahere achieved an objective response rate (ORR) of 51.9%.
Apart from Elahere, the ImmunoGen acquisition also added some other promising ADC candidates in AbbVie’s pipeline, like pivekimab sunirine (in phase II studies for blastic plasmacytoid dendritic cell neoplasm and acute myeloid leukemia) and IMGN-151 (in phase I studies for ovarian and endometrial cancers).
ADCs are next-generation treatments that target cancer cells by delivering highly potent cancer-killing agents through a targeted antibody.
Stiff Competition in the ADC Space
Through the ImmunoGen acquisition, ABBV diversified its oncology pipeline and forayed into the ADC space, which garnered interest from big pharma like AstraZeneca (AZN - Free Report) , Merck (MRK - Free Report) and Pfizer (PFE - Free Report) . These companies have made multi-billion-dollar investments in this space to develop and market novel ADC drugs.
In May, AstraZeneca announced plans to spend $1.5 billion to build its first manufacturing facility in Singapore which will cover the full manufacturing process for its ADC portfolio. AZN has a broad portfolio of in-house ADCs, including six wholly-owned ADCs in its clinical pipeline and many more in preclinical development.
This focus on ADCs comes from the success achieved by AstraZeneca from its only marketed ADC drug in its portfolio, Enhertu, which has been developed in collaboration with partner Daiichi Sankyo. Since its initial launch in 2019, Enhertu has shown an impressive initial uptake. During first-half 2024, Enhertu generated $683 million in alliance revenues for AstraZeneca, up 44% from the year-ago period’s figures.
The AZN drug is presently approved across multiple indications, including advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer (NSCLC) and metastatic HER2-positive and HER2-low breast cancer. The fifth indication, i.e., metastatic HER2-positive solid tumors, was approved by the FDA in April.
Pfizer entered into this space when it acquired ADC drugmaker Seagen last year for $43 billion. Post this acquisition, PFE added three ADCs to its portfolio — Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin) and Tivdak (tisotumab vedotin) — all approved across solid tumors and hematologic malignancies. Per the deal, Pfizer also acquired Seagen’s proprietary ADC technology.
To boost its oncology portfolio, Merck signed a deal with Daiichi Sankyo last year to jointly develop and market three investigational ADC drugs for a total potential consideration of up to $22 billion. MRK’s deal with Daiichi involves three ADCs, namely patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan, which are across multiple solid tumor indications in different stages of clinical development. Per Merck, this deal holds multi-billion dollar worldwide commercial revenue potential for each company approaching the mid-2030s.
Image: Shutterstock
EMA Committee Endorses AbbVie's Elahere in Ovarian Cancer
AbbVie (ABBV - Free Report) announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking approval for its ovarian cancer drug Elahere (mirvetuximab soravtansine) in the EU.
AbbVie’s filing seeks marketing authorization for Elahere to treat adult patients with FRα-positive, platinum-resistant and high-grade serious epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatments.
This recommendation is based on data from data from the phase III MIRASOL study, which evaluated ABBV’s drug against the investor’s choice of single-agent chemotherapy in the given patient population. The study achieved its primary endpoint — treatment with Elaherereduced the risk of tumor progression or death by 35% compared with chemotherapy.
The CHMP’s recommendation will now be reviewed by the European Commission (EC) and a final decision is expected later this year. Though the EC generally follows the CHMP recommendation, it is not bound to do so. If approved, this will be the first regulatory approval for Elahere in the EU.
ABBV Stock Performance
Year to date, AbbVie’s shares have moved up 24.9% compared with the industry’s 23.5% rise.
Image Source: Zacks Investment Research
Recent Developments Related to ABBV’s Elahere
Elahere was recently granted full approval by the FDA for a similar indication, also supported by data from the MIRASOL study. The drug was initially approved for this indication under the accelerated pathway in 2022.
A first-in-class antibody-drug conjugate (ADC), Elahere, was added to AbbVie’s portfolio earlier this year in February following the acquisition of ImmunoGen for $10.1 billion. The drug is also being evaluated in multiple studies, both as monotherapy and in combination with other drugs, for ovarian cancer, which is likely to expand its use in earlier lines of therapy and additional patient populations.
In June, AbbVie reported positive results from the phase II PICCOLO study, which evaluated Elahere in heavily pre-treated patients with FRα-positive platinum-sensitive ovarian cancer (PSOC). The study achieved its primary endpoint — patients treated with Elahere achieved an objective response rate (ORR) of 51.9%.
Apart from Elahere, the ImmunoGen acquisition also added some other promising ADC candidates in AbbVie’s pipeline, like pivekimab sunirine (in phase II studies for blastic plasmacytoid dendritic cell neoplasm and acute myeloid leukemia) and IMGN-151 (in phase I studies for ovarian and endometrial cancers).
ADCs are next-generation treatments that target cancer cells by delivering highly potent cancer-killing agents through a targeted antibody.
Stiff Competition in the ADC Space
Through the ImmunoGen acquisition, ABBV diversified its oncology pipeline and forayed into the ADC space, which garnered interest from big pharma like AstraZeneca (AZN - Free Report) , Merck (MRK - Free Report) and Pfizer (PFE - Free Report) . These companies have made multi-billion-dollar investments in this space to develop and market novel ADC drugs.
In May, AstraZeneca announced plans to spend $1.5 billion to build its first manufacturing facility in Singapore which will cover the full manufacturing process for its ADC portfolio. AZN has a broad portfolio of in-house ADCs, including six wholly-owned ADCs in its clinical pipeline and many more in preclinical development.
This focus on ADCs comes from the success achieved by AstraZeneca from its only marketed ADC drug in its portfolio, Enhertu, which has been developed in collaboration with partner Daiichi Sankyo. Since its initial launch in 2019, Enhertu has shown an impressive initial uptake. During first-half 2024, Enhertu generated $683 million in alliance revenues for AstraZeneca, up 44% from the year-ago period’s figures.
The AZN drug is presently approved across multiple indications, including advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer (NSCLC) and metastatic HER2-positive and HER2-low breast cancer. The fifth indication, i.e., metastatic HER2-positive solid tumors, was approved by the FDA in April.
Pfizer entered into this space when it acquired ADC drugmaker Seagen last year for $43 billion. Post this acquisition, PFE added three ADCs to its portfolio — Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin) and Tivdak (tisotumab vedotin) — all approved across solid tumors and hematologic malignancies. Per the deal, Pfizer also acquired Seagen’s proprietary ADC technology.
To boost its oncology portfolio, Merck signed a deal with Daiichi Sankyo last year to jointly develop and market three investigational ADC drugs for a total potential consideration of up to $22 billion. MRK’s deal with Daiichi involves three ADCs, namely patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan, which are across multiple solid tumor indications in different stages of clinical development. Per Merck, this deal holds multi-billion dollar worldwide commercial revenue potential for each company approaching the mid-2030s.
AbbVie Inc. Price
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ABBV’s Zacks Rank
AbbVie currently carries a Zacks Rank #3 (Hold).