Roopal Thakkar
Senior Vice President, Chief Medical Officer, Global Therapeutics at AbbVie
Thank you, Carrie. In 2023, we saw significant evolution of our pipeline with multiple data readouts, regulatory submissions and approvals, as well as expansion of our R&D efforts with the announced ImmunoGen and Cerevel transactions. We expect to continue this progress with numerous important clinical and regulatory milestones anticipated this year.
In immunology, we recently announced positive top line results for lutikizumab, our anti-IL-1 alpha/beta bispecific being evaluated in hidradenitis suppurativa. In the Phase II study, lutikizumab demonstrated higher high score of 50 and high score of 75 measures, as well as improvement in skin pain compared to placebo. These are very impressive results, considering all patients were inadequate responders to anti-TNF therapy and 70% of the patients were early Hurley Stage 3, which is the most advanced stage of the disease. Based on these results, we plan to begin a Phase III program in HS later this year.
We also plan to evaluate lutikizumab in ulcerative colitis and Crohn's, given the role that IL-1 likely plays in these diseases. Patients with UC, who have an IL-1 beta signature, have shown resistance to anti-TNF and other biologics, providing strong rationale for a potential biomarker approach. Additionally, we believe lutikizumab has the potential to be used in combinations to provide transformational levels of efficacy in IBD. We plan to evaluate combo approaches with lutikizumab and Skyrizi, as well as with other pipeline assets in Crohn's. Our Phase II studies in IBD are expected to begin later this year.
Our regulatory applications are under review for Skyrizi in ulcerative colitis with approval decisions expected in the US and Europe later this year. Once Skyrizi is approved in UC, along with Rinvoq, we will have two assets with different mechanisms of action in IBD, both offering very high levels of efficacy. AbbVie will be very well positioned with an industry-leading suite of treatment options for patients suffering from moderate to severe ulcerative colitis and Crohn's disease.
We continued to make very good progress with the second wave of development programs for Rinvoq with Phase III studies underway in five new indications: giant cell arteritis, lupus, HS, alopecia areata and vitiligo. We anticipate data readouts for these programs over the next three years, beginning with data from our GCA study this year.
Moving to oncology, where we continue to make very good progress across our heme and solid tumor programs. In the area of hematologic oncology, we'll see data in the second half of this year from the Venclexta Phase III VERONA trial in treatment-naive higher-risk MDS patients, with regulatory submissions and approvals anticipated in 2025. For Epkinly, we anticipate regulatory approvals in third-line or greater follicular lymphoma later this year in both the US and Europe. We also expect to begin several new Phase III studies in 2024, including studies in second-line DLBCL and frontline follicular lymphoma.
At the recent ASH Meeting, we presented new data for our BCMA/CD3 bispecific, ABBV-383, in multiple myeloma. 383 is engineered for high-affinity binding to BCMA on malignant cells and low affinity binding to a unique CD3 epitope on T-cells, which has the potential to mitigate some of the adverse events associated with other T-cell engaging BCMA-based therapies, while preserving high levels of efficacy. We're very encouraged by the data emerging from our Phase Ib study, which show treatment with 383 is yielding deep and durable responses with a lower incidence and severity of CRS. With this profile, we believe 383 can be a highly effective and tolerable treatment for multiple myeloma, while potentially allowing for outpatient administration, limited or no step-up dosing and monthly administration from the beginning of treatment, all attributes which would make it very appealing to both patients and physicians. We remain on track to begin a Phase III monotherapy study in third-line multiple myeloma this year, and we plan to begin combination trials in earlier lines of therapy in 2025.
In the area of solid tumors, we recently announced positive top line results from the Teliso-V Phase II LUMINOSITY study in previously-treated non-small cell lung cancer. Teliso-V demonstrated strong clinical benefits across key endpoints, including overall response rate, duration of response and overall survival with a tolerable safety profile. We believe these results have the potential to support accelerated approval, and we plan to discuss the data with regulators in the coming months. Pending alignment with the FDA, our submission is planned for the second half of this year.
We're also making good progress with our next-generation c-Met ADC, ABBV-400, which utilizes the same c-Met blocking antibody as Teliso-V but has a proprietary Topo-1 warhead to afford deeper and more durable responses with an improved therapeutic index. We remain on track to see data this year from the non-small cell lung cancer and gastroesophageal cohorts from our Phase I study. And based on the progress we're making in our colorectal program, we plan to begin a Phase III study later this year in third-line CRC.
We also continue to make very good progress with our anti-GARP antibody, ABBV-151. Our Phase II study in second-line hepatocellular carcinoma is underway, and we plan to begin several additional Phase II studies this year, including frontline HCC, frontline lung cancer and metastatic urothelial cancer. We look forward to providing updates on these programs as the data mature.
Now moving to neuroscience, where we recently announced the European launch of ABBV-951 for patients with advanced Parkinson's disease. We also recently provided our complete response submission to the FDA for 951 with an approval decision anticipated in the second quarter. Our novel subcutaneous levodopa/carbidopa delivery system has the potential to offer meaningful benefits over current treatment options and others that are in development. 951 delivers significant improvements in off-time and on-time with a less invasive non-surgical system. It can deliver high levodopa doses similar to the amount provided by Duopa, and it doesn't require combination with oral drugs to achieve high efficacy. 951 also provides a full 24-hour benefit, which should result in less morning akinesia. We're extremely excited to bring this transformative therapeutic option to patients in Europe and the US once approved.
In our aesthetics pipeline, we recently submitted our regulatory application in the US for Botox in platysma prominence. We anticipate an approval decision in the second half of this year. And we remain on track to complete the remaining CMC work this year for BoNTE, our rapid onset short-acting novel toxin. Following completion of the remaining work, we plan to submit our regulatory application in the second half of the year with approval anticipated near the end of 2025.
So in summary, we continue to demonstrate significant progress across all stages of our pipeline and anticipate numerous regulatory and clinical milestones again in 2024. I also look forward to integrating the ImmunoGen and Cerevel teams and pipeline assets into our R&D organization once those transactions close this year. These two transactions significantly strengthen our oncology and neuroscience pipelines with the addition of several novel assets that have the potential to become innovative new therapies for many patients.
With that, I'll turn the call over to Scott.
