
Sarah Cannon Research Institute Announces Strategic Alliance With AbbVie to Advance Novel Cancer Therapies
NASHVILLE, Tenn.--(BUSINESS WIRE)--Today, Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, announced a strategic alliance with AbbVie. The alliance aims to accelerate the development of innovative therapies for patients with cancer through collaborative scientific engagement and operational synergies to enhance the delivery of clinical trials.
"By combining SCRI's scientific and operational expertise in conducting clinical trials in the community with AbbVie's innovative drug development approach, we can further strengthen our mission to advance novel therapies for patients," said Dee Anna Smith, Chief Executive Officer, SCRI. "Working together, we can expedite the development of more treatment options and transform clinical trial delivery, providing greater access to cutting-edge therapies for patients close to home.'
SCRI's research network brings together more than 1,300 physicians who are enrolling patients to clinical trials at over 200 locations in more than 20 states across the U.S. Through the alliance, SCRI and AbbVie will enhance scientific connectivity, enabling collaboration with SCRI's physician leadership and contract research organization, SCRI Development Innovations, to drive clinical development.
'We are encouraged about the opportunity to establish a strategic scientific alliance with SCRI as we work together on initiatives aimed to address high unmet needs for patients battling cancer," said Svetlana Kobina, MD., PhD., Vice President of AbbVie Oncology, Global Medical Affairs. "Through close collaboration with SCRI and its community sites, we hope to gain a more comprehensive understanding of the treatment paths and health needs of patients living with cancer to provide tailored, patient-centered scientific solutions. This partnership enables us to delve deeper into the challenges faced by medical oncologists, hematologists, patients and caregivers to help us design clinical studies that more accurately represent all patient communities.'
The collaboration will leverage SCRI's advanced research operational capabilities through its Accelero model, which maximizes site contributions, optimizes site activation timelines, and synchronizes end-to-end clinical research management. The Accelero model utilizes SCRI's robust Personalized Medicine program, including centralized screening services to enable more seamless identification and enrollment of patients on studies. Additionally, through SCRI's streamlined data delivery solutions, SCRI can ensure timely access to data to inform drug development and optimize clinical trial delivery.
About Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI's research network brings together more than 1,300 physicians who are enrolling patients to clinical trials at over 200 locations in more than 20 states across the U.S. Visit SCRI.com to learn more.
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Medscape
15 hours ago
- Medscape
Which Class of ER Degrader Is Better?
Vepdegestrant, an investigational estrogen receptor (ER) degrader, known as a proteolysis-targeting chimera (PROTAC ), outshone the commonly used selective estrogen receptor degrader (SERD) fulvestrant in a phase 3 trial of second-line treatment for a subset of patients with breast cancer. The VERITAC-2 trial included patients with ER-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-), locally advanced or metastatic disease who had failed prior treatment with cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors and endocrine therapy, and no exposure to chemotherapy in the advanced setting. Only a subset of the study cohort, those with estrogen receptor 1-mutant disease, experienced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) when treated with vepdegestrant compared with patients treated with fulvestrant. 'These results support vepdegestrant as a potential monotherapy treatment option for patients with previously treated ESR1 -mutant ER+/HER2- advanced breast cancer,' said lead author Erika P. Hamilton, MD, a medical oncologist and director of Breast Cancer and Gynecologic Cancer Research at Sarah Cannon Research Institute, Nashville, Tennessee, during a press conference for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings were simultaneously published in the New England Journal of Medicine . Vepdegestrant is not approved by the US Food and Drug Administration, but received fast-track status in February 2024 as monotherapy for this patient population. It is the first and only PROTAC ER degrader to be evaluated in a phase 3 clinical trial in breast cancer. PROTACs represent a novel class of therapeutic agents that harness the proteasome to selectively degrade target proteins. 'There's no established consensus for patients getting treatment in the second-line setting after progression on endocrine therapy and a CDK 4/6 inhibitor,' explained Hamilton. 'One of the mainstays of our treatment really has been fulvestrant, which clearly has some challenges. First, it's administered intramuscularly, and second, in a post-CDK 4/6 landscape, we know that progression-free survival is very short — on the order of less than 2 months.' Besides fulvestrant, the oral SERD elacestrant was FDA-approved in January 2023, and other oral SERDs are in development, she noted. Trial Design The new trial included 624 patients with advanced ER+/HER2- disease that had progressed following one or two lines of endocrine therapy and a CDK 4/6 inhibitor. 'They could not have received fulvestrant already or chemotherapy, and patients had to have benefited from their previous line of endocrine therapy for at least 6 months to enter the study,' Hamilton noted. Study participants were also stratified by the presence or absence of visceral disease, as well as the presence of an ESR1 mutation (n = 270). Such mutations are a common cause of acquired resistance found in approximately 40% of patients in the second-line setting, according to a press release from the drug developer. Patients were randomly assigned 1:1 to 28-day treatment cycles of either 200 mg oral vepdegestrant once daily, or 500 mg intramuscular fulvestrant on day 1 and day 15 of the first cycle, and then on day 1 of each subsequent cycle. The primary endpoint was PFS by blinded, independent central review, first in patients with ESR1 mutations and then in the entire cohort. Key secondary endpoints were overall survival, objective response rate, and clinical benefit rate, which was defined as the rate of confirmed clinical or partial response at any time, or stable disease, nonclinical response, or nonprogressive disease for at least 24 weeks. Vepdegestrant vs Fulvestrant The study met its key primary endpoint, showing a median PFS of 5.0 months with vepdegestrant compared with 2.1 months with fulvestrant (hazard ratio [HR] 0.57; P < .001) in the 270 patients with ESR1 mutations. At 6 months, twice as many patients in the vepdegestrant arm remained progression-free compared with those in the fulvestrant arm (45.2% vs 22.7%). However, this primary endpoint was not significantly different between groups when calculated for the entire patient population (HR, 0.83; P = .07). For the key secondary endpoints, among patients with ESR1 mutations, the clinical benefit rate was more than double in patients receiving vepdegestrant (42.1% vs 20.2%). Similarly, the objective response rate was more than four times higher (18.6% vs 4%) Commenting in a press release, ASCO breast cancer expert Jane Lowe Meisel, MD, said that although the trial found that vepdegestrant worked better than fulvestrant in patients with ESR1 mutations, 'on average, patients did not have prolonged responses on either agent, highlighting the need for combination therapies and continued development in this space.' Meisel is co-director of Breast Medical Oncology at the Winship Cancer Institute of Emory University School of Medicine in Atlanta, Georgia. 'Overall survival was very immature at the time of this analysis, with only 20% of the anticipated events occurring,' added lead investigator Hamilton. Treatment-emergent adverse events (TEAEs) led to discontinuation in 3% of patients taking vepdegestrant and 1% of patients taking fulvestrant. TEAEs leading to dose reductions occurred in 2% of the vepdegestrant group and none in the fulvestrant group. The three most common AEs of any grade were fatigue (27% in vepdegestrant group, 16% fulvestrant group) and increased aspartate aminotransferase and alanine aminotransferase levels of any grade (14% vepdegestrant group, 10% fulvestrant group). Oral SERDS vs Vepdegestrant Side Effects Compared to oral SERDs, vepdegestrant has a favorable side effect profile, Hamilton said. 'Oral SERDs have prominent GI side effects as their most frequent side effect.' But, across all grades, rates of both vomiting and diarrhea were only 6% with vepdegestrant. GI side effects tend to be more common, 'in the 30% or 40% range with oral SERDs,' she told Medscape Medical News . Study discussant William John Gradishar, MD, emphasized the importance of reducing side effects. ' Vepdegestrant now joins a growing list of drugs that perform better than current standard of care monotherapy' in the ESR1 -mutant population, he noted in the session. But the reality is that most of these drugs are being developed to be used in combination with targeted therapies, 'and increased toxicity can be expected with doublet therapy…Quality of life measures as experienced and reported by patients are critical, and even modest changes in symptom and functional domains should not be minimized,' said Gradishar, professor of breast oncology at Northwestern University Feinberg School of Medicine, Chicago, Illinois. 'Vepdegestrant has demonstrated compelling preclinical activity and encouraging early clinical data supporting its efficacy in degrading ER,' said Albert Grinshpun, MD, in an interview with Medscape Medical News . Grinshpun, head of the Breast Cancer Service at Shaare Zedek Medical Center and The Hebrew University, Jerusalem, Israel, said his initial takeaway from the study is that 'vepdegestrant now stands alongside other oral SERDs, such as elacestrant and imlunestrant, in demonstrating superiority over fulvestrant, specifically in the context of ESR1 -mutant [disease].' 'Importantly, the treatment landscape for patients progressing on CDK 4/6 inhibitors is rapidly evolving, with a growing shift toward combination therapies rather than fulvestrant monotherapy,' he said. 'In my view, vepdegestrant has established itself as a promising endocrine backbone for future combination strategies. Its favorable toxicity profile makes it particularly well-suited for pairing with a range of targeted agents or even antibody-drug conjugates, including inhibitors of PIK3CA and KAT6 , in the pursuit of more effective therapeutic regimens.' The study was jointly funded by Arvinas Estrogen Receptor, Inc. and Pfizer. Hamilton disclosed consulting or advisory roles with Accutar Biotechnology (Inst), Arvinas (Inst), AstraZeneca (Inst), Circle Pharma (Inst), Daiichi Sankyo (Inst), Ellipses Pharma (Inst), Entos (Inst), Fosun Pharma (Inst), Genentech/Roche (Inst), Gilead Sciences (Inst), Janssen (Inst), Jazz Pharmaceuticals (Inst), Jefferies (Inst), Johnson & Johnson (Inst), Lilly (Inst), Medical Pharma Services (Inst), Mersana (Inst), Novartis (Inst), Olema Pharmaceuticals (Inst), Pfizer (Inst), Stemline Therapeutics (Inst), Tempus (Inst), Theratechnologies (Inst), Tubulis GmbH (Inst), Verascity Science (Inst), and Zentalis (Inst). Hamilton has also received research funding from AbbVie (Inst), Accutar Biotech (Inst), Acerta Pharma (Inst), ADC Therapeutics (Inst), Akeso Biopharma (Inst), Amgen (Inst), Aravive (Inst), ArQule (Inst), Artios (Inst), Arvinas (Inst), AstraZeneca (Inst), AtlasMedx (Inst), BeiGene (Inst), Black Diamond Therapeutics (Inst), Bliss Biopharmaceutical (Inst), Boehringer Ingelheim (Inst), Bristol-Myers Squibb (Inst), Cascadian Therapeutics (Inst), Clovis Oncology (Inst), Compugen (Inst), Context Therapeutics (Inst), Cullinan Oncology (Inst), Curis (Inst), CytomX Therapeutics (Inst), Daiichi Sankyo (Inst), Dana-Farber Cancer Institute (Inst), Dantari (Inst), Deciphera (Inst), Duality Biologics (Inst), eFFECTOR Therapeutics (Inst), Eisai (Inst), Ellipses Pharma (Inst), Elucida Oncology (Inst), EMD Serono (Inst), Fochon Pharmaceuticals (Inst), Fujifilm (Inst), G1 Therapeutics (Inst), Genentech/Roche (Inst), Gilead Sciences (Inst), H3 Biomedicine (Inst), Harpoon (Inst), Hutchison MediPharma (Inst), Immunogen (Inst), Immunomedics (Inst), Incyte (Inst), Infinity Pharmaceuticals (Inst), Inspirna (Inst), InventisBio (Inst), Jacobio (Inst), K-Group Beta (Inst), Karyopharm Therapeutics (Inst), Kind Pharmaceuticals (Inst), Leap Therapeutics (Inst), Lilly (Inst), Loxo (Inst), Lycera (Inst), MabSpace Biosciences (Inst), Macrogenics (Inst), MedImmune (Inst), Mersana (Inst), Merus (Inst), Millennium (Inst), Molecular Templates (Inst), Myriad Genetics (Inst), Novartis (Inst), Nucana (Inst), Olema Pharmaceuticals (Inst), OncoMed (Inst), Oncothyreon (Inst), ORIC Pharmaceuticals (Inst), Orinove (Inst), Orum Therapeutics (Inst), Pfizer (Inst), PharmaMar (Inst), Pieris Pharmaceuticals (Inst), Pionyr (Inst), Plexxikon (Inst), Prelude Therapeutics (Inst), ProfoundBio (Inst), Radius Health (Inst), Regeneron (Inst), Relay Therapeutics (Inst), Repertoire Immune Medicines (Inst), Rgenix (Inst), Seagen (Inst), Sermonix Pharmaceuticals (Inst), Shattuck Labs (Inst), Silverback Therapeutics (Inst), Stem CentRx (Inst), Stemline Therapeutics (Inst), Sutro Biopharma (Inst), Syndax (Inst), Syros Pharmaceuticals (Inst), Taiho Pharmaceutical (Inst), TapImmune Inc. (Inst), Tesaro (Inst), Tolmar (Inst), Torque (Inst), Treadwell Therapeutics (Inst), Verastem (Inst), Zenith Epigenetics (Inst), and Zymeworks (Inst). Meisel disclosed consulting or advisory roles with AstraZeneca, GE Healthcare, Genentech, Novartis, Olema Oncology, Pfizer, SeaGen, Sermonix Pharmaceuticals, and Stemline, and research funding from AstraZeneca (Inst), Olema Oncology (Inst), Pfizer (Inst), Seagen (Inst), and Sermonix Pharmaceuticals (Inst). Grinshpun disclosed honoraria from GSK, Lilly, Novartis, and AstraZeneca, and travel from Roche, Pfizer, and AstraZeneca. Gradishar disclosed consulting or advisory roles with AstraZeneca , Genentech/Roche, Gilead Sciences, Merck, Novartis, Pfizer.
Yahoo
4 days ago
- Yahoo
AbbVie Stock Down Around 13% in 3 Months: Time to Buy the Dip?
AbbVie ABBV stock has declined 12.6% in the past three months. The stock is also trading below its 50-day and 200-day moving averages. A lot of this price decline is related to the broader macroeconomic uncertainty. The sky-high tariffs imposed by the United States and retaliatory tariffs by China and some other countries hurt global stock markets. Although the massive tariffs imposed by the United States and China are currently on pause, this is only a temporary suspension. The uncertainty around tariffs and trade production measures remains, which has muted economic growth. Although pharmaceuticals have been exempted from tariffs in the first round, they could be Trump's target in the next round, considering the President's goal to shift pharmaceutical production back to the United States, primarily from European and Asian countries. Let's understand ABBV's strengths and weaknesses to better analyze how to play the stock in the uncertain macro environment. AbbVie lost patent protection for Humira in the United States in January 2023 and in the EU in 2018. Humira's sales are declining due to the loss of exclusivity ('LOE') and biosimilar erosion. However, with approvals for many new indications, sales of Skyrizi and Rinvoq have successfully replaced Humira, which once generated more than 50% of its total revenues. Skyrizi and Rinvoq generated combined sales of $5.1 billion in the first quarter of 2025, reflecting growth of more than 65%. The drugs are seeing strong performance across all their approved indications, especially in the popular inflammatory bowel disease (IBD) space, which includes two conditions — ulcerative colitis (UC) and Crohn's disease (CD). Importantly, Skyrizi and Rinvoq have demonstrated compelling head-to-head data against several novel therapies in clinical studies, which have given them a competitive advantage. AbbVie expects combined sales of Skyrizi and Rinvoq to be around $24.7 billion in 2025 and more than $31 billion by 2027. Strong immunology market growth, market share gains and momentum from new indications, such as the recent launch of Skyrizi in UC, as well as the potential for five new indications for Rinvoq over the next few years, are expected to drive these drugs' growth. AbbVie has several early/mid-stage pipeline candidates with blockbuster potential. The company expects several regulatory submissions, approvals and key data readouts in the next 12 months. ABBV has an exciting and diverse pipeline of promising new therapies in blood cancers and solid tumors, like ABBV-383, a BCMA CD3 bispecific (relapsed/refractory multiple myeloma) and Temab-A (metastatic colorectal cancer). 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In early 2025, AbbVie bought rights to develop GUB014295 (ABBV-295), a long-acting amylin analog for the treatment of obesity, from Denmark's Gubra. The deal marked AbbVie's entry into the obesity space, dominated by Eli Lilly LLY and Novo Nordisk NVO. AbbVie plans to invest further in obesity. Sales of AbbVie's blockbuster drug Humira are declining due to biosimilar erosion. Humira volume is rapidly eroding to other novel mechanisms (including Skyrizi and Rinvoq). Humira sales declined almost 50% in the first quarter of 2025 due to faster share erosion from biosimilar competition as well as further molecule compression in the United States. AbbVie is witnessing declining sales of Juvederm fillers in the United States and China due to challenging market conditions. The slowing growth of the U.S. facial injectables market and persistent economic headwinds, which are affecting consumer spending in China, are hurting AbbVie's aesthetics portfolio sales, which declined 10.2% in the first quarter of 2025. AbbVie's stock has gained 5% so far this year against a decrease of 3% for the industry. The stock has also outperformed the industry and the S&P 500 index, as seen in the chart below. Image Source: Zacks Investment Research From a valuation standpoint, AbbVie is not very cheap. Going by the price/earnings ratio, the company's shares currently trade at 14.08 forward earnings, just slightly lower than 14.7 for the industry. The stock is cheaper than some other large drugmakers like Eli Lilly and Novo Nordisk but priced much higher than most other large drugmakers. The stock is also trading above its five-year mean of 12.35. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2025 earnings has risen from $12.22 per share to $12.28, while that for 2026 has increased from $14.03 to $14.05 per share over the past 30 days. Image Source: Zacks Investment Research AbbVie faces its share of near-term headwinds like Humira's biosimilar erosion, increasing competitive pressure on its cancer drug, Imbruvica, and slowing sales of its aesthetics products. However, AbbVie has successfully navigated the LOE of its blockbuster drug, Humira, by launching two other successful new immunology medicines, Skyrizi and Rinvoq, which are performing extremely well, bolstered by approvals in new indications and should support top-line growth in the next few years. AbbVie expects to return to robust revenue growth in 2025, which is just the second year following the U.S. Humira LOE, driven by its ex-Humira platform. AbbVie's ex-Humira drugs rose delivered robust sales growth of more than 21% (on a reported basis) in the first quarter of 2025. Boosted by its new product launches, AbbVie expects to return to robust mid-single-digit revenue growth in 2025 with a high single-digit CAGR through 2029, as it has no significant LOE event for the rest of this decade. A substantial portion of this growth is expected to be driven by robust performances from Skyrizi and Rinvoq. Rising estimates for AbbVie, its solid pipeline and the prospect of growth in 2025 sales and profits are good enough reasons to stay invested in this Zacks Rank #3 (Hold) stock. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In fact, long-term investors may buy the stock on the recent dip. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio


Business Wire
5 days ago
- Business Wire
Sarah Cannon Research Institute Announces Strategic Alliance With AbbVie to Advance Novel Cancer Therapies
NASHVILLE, Tenn.--(BUSINESS WIRE)--Today, Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, announced a strategic alliance with AbbVie. The alliance aims to accelerate the development of innovative therapies for patients with cancer through collaborative scientific engagement and operational synergies to enhance the delivery of clinical trials. "By combining SCRI's scientific and operational expertise in conducting clinical trials in the community with AbbVie's innovative drug development approach, we can further strengthen our mission to advance novel therapies for patients," said Dee Anna Smith, Chief Executive Officer, SCRI. "Working together, we can expedite the development of more treatment options and transform clinical trial delivery, providing greater access to cutting-edge therapies for patients close to home.' SCRI's research network brings together more than 1,300 physicians who are enrolling patients to clinical trials at over 200 locations in more than 20 states across the U.S. Through the alliance, SCRI and AbbVie will enhance scientific connectivity, enabling collaboration with SCRI's physician leadership and contract research organization, SCRI Development Innovations, to drive clinical development. 'We are encouraged about the opportunity to establish a strategic scientific alliance with SCRI as we work together on initiatives aimed to address high unmet needs for patients battling cancer," said Svetlana Kobina, MD., PhD., Vice President of AbbVie Oncology, Global Medical Affairs. "Through close collaboration with SCRI and its community sites, we hope to gain a more comprehensive understanding of the treatment paths and health needs of patients living with cancer to provide tailored, patient-centered scientific solutions. This partnership enables us to delve deeper into the challenges faced by medical oncologists, hematologists, patients and caregivers to help us design clinical studies that more accurately represent all patient communities.' The collaboration will leverage SCRI's advanced research operational capabilities through its Accelero model, which maximizes site contributions, optimizes site activation timelines, and synchronizes end-to-end clinical research management. The Accelero model utilizes SCRI's robust Personalized Medicine program, including centralized screening services to enable more seamless identification and enrollment of patients on studies. Additionally, through SCRI's streamlined data delivery solutions, SCRI can ensure timely access to data to inform drug development and optimize clinical trial delivery. About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI's research network brings together more than 1,300 physicians who are enrolling patients to clinical trials at over 200 locations in more than 20 states across the U.S. Visit to learn more.