Thomas Hudson
Senior Vice President, Research and Development, Chief Scientific Officer at AbbVie
Thank you, Carrie. We've continued to make very good progress with our pipeline over the quarter. We had a substantial amount of activity across our R&D pipeline, resulting in new approvals and advancements of several programs. In Immunology, we received FDA approval for Rinvoq in Crohn's disease, marking its seventh FDA approval across gastroenterology, rheumatology and dermatology. In our Crohn's development program, Rinvoq demonstrated a very rapid and strong impact on symptoms as well as endoscopic improvement. Given its strong benefit-risk profile, we believe Rinvoq will be an important new medicine for patients suffering from moderate to severe Crohn's disease. While Crohn's disease approval marks the completion of the core indications, we believe Rinvoq has the potential to become a highly effective therapy in several additional important diseases.
We recently began Phase 3 studies for Rinvoq in systemic lupus and hidradenitis suppurativa, and we remain on-track to begin Phase 3 studies in alopecia areata later this year. We'll also see data later this year from a Phase 2 study in vitiligo, which could support advancement to Phase 3 in this indication as well.
Moving to Skyrizi, where in the quarter, we announced positive topline results from our Phase 3 maintenance trial in ulcerative colitis. In this study, Skyrizi met the primary and key secondary endpoints at week 52 compared to the withdrawal arm, demonstrating that patients continuing treatment with Skyrizi maintained high levels of clinical remission as well as more stringent endpoints, such as endoscopic improvement, histologic, endoscopic mucosal improvement and steroid-free remission. It's important to note that approximately 75% of the patients in this study had failed advanced therapy, including not only anti-TNFs, but also other biologics, JAK inhibitors and S1P modulators. This represents a very difficult-to-treat population in ulcerative colitis, Skyrizi's strong performance in patients with and without failure to advance therapies, including patients who were naive to advanced therapy demonstrate its utility across the spectrum of moderate-to-severe UC patients. We remain on-track to submit our regulatory applications in the third quarter with approvals anticipated in 2024.
We also recently published results from a head-to-head trial, comparing Skyrizi to Otezla in patients with moderate psoriasis, with Skyrizi demonstrating clear superiority to Otezla on all primary and ranked secondary endpoints at week 16 and 52. At week 52 of the study, 64% of patients achieved absolute skin clearance as measured by PASI 100 and sPGA clear compared to just 3% for Otezla, underscoring Skyrizi's ability to drive very high and durable responses in these moderate patients. In addition to higher clinical efficacy outcomes, the patients treated with Skyrizi, which is a self injectable administered quarterly, reported improvements in health-related quality-of-life measures and greater treatment satisfaction compared to those treated with Otezla, which is an oral administered twice daily.
Additionally Skyrizi demonstrated favorable safety and tolerability compared to Otezla. The rates of adverse events, including serious and severe AEs were numerically higher with Otezla than with Skyrizi treatment. Previous to -- similar to previous studies, Otezla treatment was associated with high rates of a gastrointestinal distress, such as nausea, diarrhea and vomiting, which resulted in a 7% discontinuation rate in the first 16 weeks of treatment compared to no discontinuations for Skyrizi patients. We're incredibly pleased with these results, which further underscores Skyrizi's position as a best-in-category treatment for moderate to severe psoriasis, providing very high efficacy, durable responses, a safe and tolerable profile and convenient quarterly administration.
In Oncology, we received accelerated approval in the U.S. for Epkinly as a monotherapy treatment for patients with relapsed or refractory DLBCL, who had received two or more systemic therapies. We also recently received positive CHMP opinion, with an approval decision in Europe expected later this year. DLBCL is a very aggressive disease, where later-line patients have limited options. We're extremely excited to bring this new subcutaneous treatment option to patients.
In the quarter, we also announced positive topline results from the follicular lymphoma cohort of a Phase 2 trial, evaluating Epkinly in patients who have received at least two prior lines of therapy. In this study, Epkinly performed very well as a monotherapy, demonstrating an overall response rate of 82%. We are pleased with these results and plan to discuss these data with regulatory agencies about the potential to support a submission for accelerated approval. Beyond the mid-stage studies, supporting accelerated approvals in later lines of therapy, we also have Phase 3 trials ongoing in earlier lines of DLBCL and follicular lymphoma and we look forward to providing updates on these programs as the data mature.
In our Navitoclax program, we recently saw topline results from the Phase 3 Transform-1 trial, evaluating Navitoclax in combination with ruxolitinib for patients with treatment naive myelofibrosis. The study met the primary endpoint at week 24, demonstrating a statistically significant improvement in the percentage of patients who achieved spleen volume reduction of at least 35% compared to rux plus placebo. For the primary endpoint, the Navitoclax combination showed the doubling of improvement over rux alone, with 63% of patients on the Navitoclax combination achieving SVR35 compared to 32% in the rux plus placebo combination. In this study, the Navitoclax combination did not achieve the first ranked secondary endpoint, which was improvement in total symptom score at week 24. Additional follow-up data on SVR and TSS, as well as other endpoints, are expected in the fourth quarter of this year. We plan to wait for these more mature data before engaging with regulatory agencies in order to have a more comprehensive picture of the patients' clinical response and clinical benefit that Navitoclax can provide.
Looking to the remainder of this year, we remain on-track for several additional data readouts from our late-stage oncology programs, including Phase 3 data from Venclexta's CANOVA trial in relapsed refractory multiple myeloma patients, with t(11;14) mutation. As a reminder, this is an event-driven study and we're just waiting -- we're waiting for just a handful of remaining events. So, we'd expect to have these data in-house in the coming months. And we remain on-track to see Phase 2 data for Teliso-V in second-line plus advanced non-squamous, non-small cell lung cancer in the fourth quarter.
We're also making very good progress with several earlier line earlier-stage solid tumor programs. We recently initiated a Phase 2 study for ABBV-151, our anti-GARP antibody in hepatocellular carcinoma and plan to begin Phase 2 in several additional solid tumors over the course of the next 12 months. At the recent ASCO Meeting, we presented promising initial results from a Phase 1 study, evaluating our next-generation cMet ADC ABBV-400 in several advanced solid tumor types. We're seeing responses across multiple tumors, indicating broad activity. Results in late-line colorectal patients were particularly encouraging, where monotherapy treatment with 400 resulted in a confirmed overall response rate of 22%, well in excess of standard-of-care, which is typically less than 2% to 3%. We're also encouraged by the durability of response seen in these early results. These patients had an average of five prior lines of therapy. So, this level of efficacy is very encouraging. Based on these results, we plan to start our Phase 2 program later this year, beginning with the second-line colorectal cancer study.
Now moving to Neuroscience, where in the quarter, we received a positive CHMP opinion, recommending approval of atogepant for migraine prevention. We anticipate a decision in the coming months. And if approved, atogepant would be the only oral CGRP antagonist approved in Europe for prevention of both episodic and chronic migraine. This is a debilitating condition that impacts tens of millions of people in Europe and we look forward to making this new oral treatment option available to patients once approved. Also in the area of Neuroscience, ABBV-906, our a-beta antibody for Alzheimer's disease is rapidly advancing through dose-escalation studies. This antibody is demonstrating a long half-life and very low anti-drug antibodies, both important attributes to achieve a best-in-class profile for our a-beta antibody. Dose selection in Phase 2 is expected to begin early next year.
And lastly, in our Aesthetics pipeline, we recently submitted our regulatory application for Botox in masseter muscle prominence in China, which is the initial focus for our program, given the prevalence of masseter muscle prominence in Asian populations and a significant unmet need for minimally-invasive treatment options. In our Platysma Prominence program for Botox, we remain on-track to see data from two additional Phase 3 studies later this year, with our regulatory submission in the U.S. expected near the end of the year.
So, in summary, we had a very productive first-half of the year across all stages and therapeutic areas of our pipeline and we look forward to the second-half of 2023 with several important clinical and regulatory milestones.
With that, I'll turn the call over to Scott.
