Roopal Thakkar
Executive Vice President, Research and Development and CSO at AbbVie
Thank you, Carrie. We continue to make very good progress advancing our pipeline with several regulatory and clinical milestones since our last earnings call. I will start with immunology. We received FDA approval for Skyrizi in ulcerative colitis, which marks its second inflammatory bowel disease indication. Skyrizi is now the only IL-23 specific inhibitor approved for both ulcerative colitis and Crohns disease.
Skyrizi has proven to be a highly effective, durable, safe and well-tolerated treatment option for patients with moderate to severe inflammatory bowel disease. And this recent approval further strengthens AbbVies leadership position in this market. We also received a positive CHMP opinion recommending Skyrizi for the treatment of moderate to severe ulcerative colitis in Europe, with an approval decision anticipated soon.
Earlier this month, we submitted our regulatory applications in the U.S. and Europe for Rinvoq and giant cell arteritis. Our submissions are based on the previously announced Phase 3 results from our SELECT-GCA trial, where Rinvoq demonstrated superiority compared to placebo on sustained remission from week 12 through week 52 on disease flare and showed a reduction in total steroid exposure at week 52. We expect approval decisions for this indication next year.
We also recently began a Phase three study for lutikizumab, our anti-IL-1-alpha-beta-bispecific in hidradenitis suppurativa. HS is a skin disease that can be debilitating and there are limited treatment options. In our Phase two study, lutikizumab demonstrated strong clinical response rates and improvement in skin pain in a very refractory patient population. Based on these results, we believe lutikizumab has the potential to become an important new treatment option for patients with moderate to severe HS. We look forward to providing updates on the Phase three program as the data become available.
In the second quarter, we announced two additional immunology transactions as we continue to invest in external innovation to expand our pipeline. These include the acquisition of Celsius Therapeutics, which brings a Phase 2 ready anti-TREM1 antibody for IBD and a license agreement with FutureGen to develop a next-generation anti-TL1A antibody for IBD that is designed to have less frequent dosing compared to other TL1As in development and will be evaluated in combination with Skyrizi.
This follows the four immunology deals we announced earlier this year, which, as a reminder, included the acquisition of Landos and their oral NLRX1 agonist in Phase 2 for UC, a partnership with OSE to develop a novel ChemR23 agonist for IBD and RA, a collaboration with Parvus to utilize their immune tolerization platform for novel IBD therapies and a collaboration with Tentarix to develop conditionally active multi-specific biologics in immunology and oncology.
Moving to oncology, where we continue to make very good progress across all stages of our heme and solid tumor pipeline. In the area of solid tumors, we recently announced positive topline results from our Phase 2 PICCOLO study evaluating Elahere as a monotherapy in ER alpha positive third-line plus platinum-sensitive ovarian cancer for those not eligible for retreatment with platinum-based therapies. Elahere met the primary and key secondary endpoints in the study, demonstrating an objective response rate of 52% and median duration of response of 8.25 month. Detailed results will be presented at an upcoming medical congress.
Following discussions with the FDA, we will be submitting to Teliso-V for accelerated approval as a monotherapy in patients with previously treated c-Met overexpressing EGFR wild-type non-squamous, non-small-cell lung cancer. This submission will be reviewed under FDAs real-time oncology review program. Teliso-V has also received breakthrough therapy designation from the FDA.
Our submission will be based on the results of our Phase 2 LUMINOSITY study, where Teliso-V demonstrated strong clinical benefits across key endpoints, including overall response rate, duration of response and overall survival, with a tolerable safety profile. Submission is expected in the third quarter, with an approval decision anticipated in 2025. The confirmatory Phase 3 study for this potential accelerated approval is currently ongoing.
We continue to see encouraging data for ABBV-400, our next generation c-Met ADC, which uses a topo payload. Recall that weve advanced 400 in late-line colorectal cancer based on the deep responses and prolonged durability observed as a monotherapy in our Phase 1 trial. And we remain on track to begin a Phase 3 study later this year in third-line CRC.
Were also seeing encouraging signals of activity for this next-gen ADC in the non-small-cell lung cancer cohort from our Phase 1 study. The preliminary data will be presented at an upcoming medical meeting. And based on the emerging Phase 1 results, we plan to begin a Phase 2 program for 400 in lung cancer.
In the area of hematologic oncology, we received accelerated approval in the U.S. for Epkinly as a monotherapy treatment for patients with relapsed refractory follicular lymphoma after two or more lines of prior therapy. Epkinly is now the only T-cell engaging bispecific approved in the U.S. to treat both follicular lymphoma and diffuse large B-cell lymphoma. Were extremely excited to bring this new subcutaneous treatment option to patients suffering from follicular lymphoma. We also recently received positive CHMP opinion with an approval decision in Europe expected later this year.
In the quarter, we initiated a Phase 3 monotherapy study for ABBV-383 in third-line multiple myeloma. 383 is designed 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 remain excited about this assets potential to become a best-in-class BCMA CD3 bispecific by providing deep, durable responses and low incidence and severity of CRS, with the potential for outpatient administration, limited or no step-up dosing and monthly administration from the beginning of treatment.
In addition to our Phase 3 monotherapy program, we have an ongoing Phase 1 study in later lines of multiple myeloma to evaluate 383 in various combinations, including with Pomalyst, Revlimid and Darzalex. Based on this work, we will begin Phase 2 combination studies in earlier lines of therapy next year.
Moving to neuroscience, where in the quarter we announced that we received a complete response letter for our 951 regulatory application in the U.S. The CRL is based on observations identified during an inspection at a third-party manufacturing site that was unrelated to 951.
The CRL did not identify any issues related to the safety, efficacy or labeling of 951, nor has the FDA requested any additional clinical data or device-related testing. Were working closely with the site and the FDA to get clarity on timelines and well provide updates as soon as information becomes available.
Moving to an update on one of our Alzheimers disease programs. We recently completed an interim analysis of a Phase 2 study evaluating ABBV-916, our A-beta antibody. The emerging efficacy and safety profile in this study is similar to what has been demonstrated by approved agents. However, given the evolving landscape, we do not believe 916 as a monotherapy treatment will be sufficiently differentiated from other emerging therapies. As a result, we are discontinuing further development for 916 as a standalone antibody.
As Rob mentioned, we remain on track to close the Cerevel transaction soon and we look forward to welcoming the team into our R&D organization. The emraclidine pivotal studies in schizophrenia remain on track to begin reading out near the end of this year. Well also see data from two additional Phase 3 studies for davapidon in Parkinson's disease later this year. We look forward to providing updates on these programs once the transaction has closed and data are available.
In aesthetics, we recently received approval for Botox in China for masseter muscle prominence, marking the first global approval in this indication for any neurotoxin. Masseter prominence is common in Asian populations and there is significant unmet need for minimally invasive treatment options. We anticipate high demand for Botox in this novel indication in China, which will help to further build our portfolio in the face-shaping segment.
A regulatory application is under review in the U.S. for Botox and platysma prominence, which is another novel indication that will help build our position in the lower face and neck segment. We continue to expect an FDA approval decision later this year.
And we remain on track to submit a regulatory application for BoNT/E near the end of this year. A rapid-onset, short-acting toxin has a highly differentiated clinical profile and once approved would offer patients a novel option compared to currently available toxins.
So, in summary, we've made great progress across all of our therapeutic areas in the first half of the year and we look forward to additional data readouts, regulatory submissions and approvals throughout the remainder of 2024.
With that, Ill turn the call over to Scott.
