Bullish options flow was detected in ABBV stock on December 12, 2019.
11,651 calls trading, 2.0x expected, and implied vol increasing over 1 point to 21.87%. Jan-20 90 calls and Dec-19 85 puts are the most active options, with total volume in those strikes near 6,600 contracts.
On December 9, 2019, AbbVie and Scripps Research announced a collaboration to develop new therapies for a range of diseases, including in the therapeutic areas of oncology, immunology, neurology and fibrosis. In addition to programs initially named in the collaboration from preclinical to IND stages of development, Scripps Research will present to AbbVie a certain number of preclinical programs of mutual interest per year for consideration to be included in the collaboration. Scripps and AbbVie will also work together in parallel to advance CD3 bispecifics against oncology targets nominated by AbbVie. Under the terms of the license agreement, Scripps Research will continue to conduct pre-clinical research and development activities and, in some cases, Phase 1 clinical trials with AbbVie having an exclusive option to further develop and commercialize. Upon AbbVie’s decision to exercise its option to a given program, Scripps Research is eligible to receive additional payments from AbbVie, including option exercise fees, success-based development and commercial milestone payments, as well as tiered royalties. AbbVie will make an undisclosed upfront payment, as well as a near-term milestone payment upon achievement of certain success criteria.
Also on December 9, 2019, Adaptive Biotechnologies (ADPT) announced a multi-year, global collaboration agreement with AbbVie (ABBV) to utilize Adaptive’s next-generation sequencing, or NGS,-based clonoSEQ Assay to assess minimal residual disease, or MRD, status in response to venetoclax across multiple myeloma, or MM, clinical trials.
“Adaptive is thrilled to partner with AbbVie to support the clinical development and potential regulatory approval of venetoclax in multiple myeloma,” said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. “This partnership supports the growing use of clonoSEQ in drug development as an accurate, reliable method to assess response to new treatments that can meaningfully improve patient care.”
On December 8, 2019, AbbVie (NYSE: ABBV) presented long-term data from a post-hoc analysis, further supporting the sustained clinical benefit of fixed duration treatment with VENCLEXTA®/VENCLYXTO® (venetoclax) in combination with rituximab (VenR) in patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL). The updated data from the Phase 3 MURANO trial four-year analysis (median follow-up of 48 months with all patients off VENCLEXTA/VENCLYXTO treatment for a median of 22 months) showed that patients with R/R CLL who completed the chemotherapy-free, two-year fixed duration course of VENCLEXTA/VENCLYXTO treatment combination maintained progression-free survival (PFS) and overall survival (OS). Patients who completed treatment with the VENCLEXTA/VENCLYXTO combination also achieved higher rates of minimal residual disease (MRD)-negativity and complete remissions compared to those treated with a standard of care, bendamustine plus rituximab (BR).1 The full results were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition (abstract #355).
“These results support the benefits of a fixed duration of treatment with venetoclax to reduce the risk of disease progression or death in patients with chronic lymphocytic leukemia,” said Mohammed Zaki, M.D., Ph.D., vice president, global head of hematology development at AbbVie. “We remain committed to understanding the full utility of venetoclax combinations and to advancing other clinical development programs with the potential to transform the standards of care for patients with blood cancers.”
“In the four-year analysis from the MURANO trial, treatment with the venetoclax combination resulted in an 81 percent reduction in the risk of progression or death compared to the standard of care,” said Professor John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and director of the Department of Hematology at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Australia. “The sustained efficacy and manageable safety profile observed in the study further support the clinical benefits of fixed treatment in patients with relapsed or refractory chronic lymphocytic leukemia.”
In the post-hoc analysis, median follow-up for patients who completed two years of treatment with the venetoclax combination without progressive disease (n=130) was 22 months (range: 1 to 35 months). PFS (HR, 0.19, 95% CI: 0.14, 0.25, descriptive p<0.0001) and OS (HR 0.41, 95% CI: 0.26,0.65, descriptive p<0.0001) remained durable for patients taking VenR compared to those taking BR. Twenty-four months after patients were off therapy, the investigator (INV)-assessed estimated PFS was 57.3% (95% CI 49.4, 65.3) versus estimated PFS of 4.6% (95% CI, 0.1, 9.2) in patients taking BR. Additionally, the OS analysis showed a four-year event-free rate of 85.3% (95% CI: 89.2, 99.0) in the venetoclax arm compared to 66.8% for BR (medians not reached). The improvements in both PFS and OS were observed despite 79% of patients in the control arm receiving an additional targeted CLL treatment after disease progression.
By the end of treatment, 64% of patients had achieved MRD-negativity, and 87% of those patients remained free of disease progression two years post-treatment. MRD-negativity is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment. Achieving MRD-negativity was assessed as a secondary endpoint because it is associated with improved clinical outcomes. Higher rates of MRD-negativity were observed off treatment in patients taking VenR than in those taking standard of care BR.
The safety profile of the combination is consistent with the known safety profile of each individual therapy alone. There were no new serious safety issues observed in the MURANO study since the last update. Excluding non-melanoma skin cancer, there was one report of melanoma in the standard of care cohort, and one report of melanoma and one report of breast cancer in the venetoclax combination cohort.
Venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of Roche Group, in the U.S. and by AbbVie outside the U.S.
On December 6, 2019, AbbVie (NYSE: ABBV) announced an agreement was reached with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.
“Although the introduction of biologics has improved treatment outcomes, many patients continue to live with their needs unmet. Patients strive for therapies that provide predictable and durable full skin clearance with convenient dosing. Ultimately, they want a therapy that improves their quality of life,” Dr. Kim Papp, Probity Medical Research Inc. ”It is great news to know that more Canadians will have access to a new treatment option.”
SKYRIZI™ received Health Canada approval in April 2019 based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis. SKYRIZI™ is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
Canadians living with moderate to severe plaque psoriasis were well represented in all four of the pivotal clinical trials leading to Health Canada’s approval, showing the Canadian leadership in this clinical development program. In clinical studies, SKYRIZI™ significantly improved levels of skin clearance after just 16 weeks and maintained clearance at one year (52 weeks).
“We are committed to continuing to improve the lives of those living with psoriasis where there is still much to be done,” explains Stéphane Lassignardie, Vice-President and General Manager, AbbVie Canada. “We are extremely proud that SKYRIZI™ is the first IL-23 inhibitor to reach an agreement with the pCPA. This is a great step forward for Canadians to obtain access to this innovative therapy.”