Merdad Parsey
Chief Medical Officer at Gilead Sciences
Thank you, Joanna. I'm pleased to highlight the ongoing progress our teams have made with 64 ongoing clinical programs and 21 Phase 3 trails. Notably, we presented multiple positive data readouts at medical conferences in the second quarter, such as updated overall survival data for Trodelvy in pre-treated HR+/HER2- metastatic breast cancer, OS data for Yescarta in second-line relapsed or refractory large B-cell lymphoma, and long-term data from blabber tied in HDV.
As we move into the second half of 2023, we remain focused on execution, investing in capabilities to increase our productivity and portfolio prioritization. We also look-forward to sharing an update on Trodelvy in non-small cell lung cancer, including EVOKE-02 data at World Conference on Lung Cancer in September.
Turning first to Virology on slide 16, we are proud of the role Gilead has played in transforming HIV care. We continue to innovate based on our commitment to both the HIV community and to those who could benefit from prevention regimen with our ongoing work to do over new effective and convenient options. The unique profile of lenacapavir, our first-in class capsid inhibitor enables the eight prevention and treatment clinical programs, we're focused on.
In HIV treatment the ARTISTRY-1 trial evaluating oral once daily bictegravir and lenacapavir your combination regimen. It's progressing well. We expect to provide an update on the Phase 2 portion of the study later this year. This novel regimen aims to provide an effective and simpler regimen for the 6% to 8% a biologically suppressed individuals who are currently on complex multi tablet regimens to manage their HIV.
We continue to advance in our goal of providing longer-acting HIV treatment options through the development of lenacapavir combination regimens with integrase inhibitors, NRTIs and NNRTI as well as the Phase 2 study of our two broadly neutralizing antibodies.
In HIV prevention, recruitment for our Phase 3 PURPOSE-1/-2 clinical trials evaluating every six months single-agent subcutaneous lenacapavir continues to exceed our expectations in the second quarter. We look-forward to potentially providing a data update in late 2024, to early 2025 timeframe as we target approval in late 2025.
Moving on to slide 17, I'm pleased to note that the European Association for the Study of the Liver or EASL has updated its HDV guidelines to recommend that all patients in the EU with chronic HDV infection, should be considered for antiviral treatments.
Recently Hepcludex was granted full approval by the European commission remains the only approved therapy for chronic HCV infection in the EU. The updated guidelines were supported by Hepcludex 's 48-week data which were published in the New England Journal of Medicine in June.
Gilead also presented data demonstrating the 96-week treatment with bulevirtide improved biologic and biochemical responses with no evidence of treatment-emergent resistance, including those who were previously non or partial responders. These data reinforce our confidence in bulevirtide and its potentially longer-term benefit for patients with HDV. As a reminder, bulevirtide is not yet approved in the US.
Turning to Oncology on slide 18. Trodelvy remains the first and only approved TROP2-directed ADC with indications across three tumor types. It's also the only TROP2-directed ADC to show overall survival benefit versus chemotherapy in two tumor types. We've now treated over 20,000 patients and evaluate more than 2300 patients in our clinical trials. Trodelvy's robust dataset informs a well-characterized safety profile with low discontinuation rates observed across multiple indications and no required increasing monitoring for severe interstitial lung disease.
At ASCO, we presented additional data demonstrating Trodelvy's potential, including in pre-treated HR+/HER2- metastatic breast cancer. We presented the final analysis from our Phase 3 TROPiCS-02 trial supporting the marketing authorization we just received from the European Commission last week.
In bladder cancer, we shared an analysis of TROPHY-U-01 supporting Trodelvy's efficacy in post-platinum post-IO metastatic urothelial cancer across a range of TROP-2 expression. With our accelerated approval in bladder cancer, we hope to provide a data update from the ongoing confirmatory Phase 3 TROPiCS-04 trail and initiate global filings for Trodelvy in metastatic urothelial cancer by the end of next year. In heavily pre-treated endometrial cancer, we presented promising efficacy data from our Phase 2 TROPiCS-03 Basket trial, demonstrating the expanding pan-tumor potential of Trodelvy.
Moving to slide 19, our comprehensive clinical development program in non-small cell lung cancer includes several signal-seeking and ongoing Phase 3 clinical trials. We know non-small cell lung cancer is not only an area of significant unmet need, as the number-one cause of cancer-related death, but also an area we believe Trodelvy has the potential to transform standard-of-care as a combination partner to an IO backbone in the first-line setting, as well as a single-agent in the post-IO setting.
On slide 20, we highlight the growing number of lung-related catalysts. I'm particularly excited to highlight that we've added a new milestone with a preliminary readout from our Phase 2 EVOKE-02 trial at the World Conference on Lung Cancer.
This study is evaluating Trodelvy plus pembrolizumab, with or without chemo in first-line non-small cell lung cancer. We will be sharing data from the first two cohorts evaluating Trodelvy in combination with pembro in PD-L1 high and PD-L1 low patients. The abstract, expected to be released later in August, will be an initial subset of a small number of patients. Our presentation scheduled for Sunday, September 10th at World Lung will include data at a later cut-off date with more patients.
Turning to domvanalimab, or dom, on slide 21, we presented data from the last interim analysis of the full 150 patients enrolled in the Phase 2 ARC-7 study at ASCO in June. The data continued to show consistent and clinically meaningful improvement in progression-free survival in first-line PD-L1 high non-small cell lung cancer, when dom, our Fc-silent anti-TIGIT is combined with an investigational anti-PD1 agent as compared to the PD1 inhibitor alone. These data form the basis for our dom program encompassing Phase 3 trials in first-line non-small cell lung cancer and upper GI cancers.
Moving to cell therapy on slide 22. Yescarta continues to strengthen its position as a cell therapy of choice for large B-cell lymphoma. At ASCO in June, we presented overall survival data from the landmark Phase 3 ZUMA-7 trial of Yescarta in second-line relapsed or refractory large B-cell lymphoma.
At a median follow-up of four years, a one-time treatment with Yescarta demonstrated a statistically significant longer overall survival compared to standard-of-care with a 27% reduction in risk of death, representing a 38% relative improvement. Moreover, the majority of the patients in the standard-of-care arm eventually received a cell therapy off protocol.
And of those, 77% received Yescarta. Overall, Yescarta is the first treatment in nearly 30 years to demonstrate a significant improvement in survival for this patient population, and these data add to the growing body of evidence that position cell therapy as potentially curative in some populations.
With a strong pipeline of six ongoing Phase 2 and 3 trials across lines of therapy, new tumor types, and earlier-stage assets, Kite continues to innovate and execute on expanding the potential benefit of cell therapies to new patients, both through internal or acquired innovation and through collaborations. We are working closely with one of these partners, Arcellx, to support their efforts regarding the IMAGINE-1 clinical hold. We remain confident in the therapeutic profile for CAR-T ddBCMA and IMAGINE-1 trial based on the data demonstrated to date, and sharing Arcellx's commitment to delivering this novel therapy to multiple myeloma patients.
Turning to slide 23, we highlight our progress against key clinical milestones for 2023 so far. We are of course disappointed by the outcome of the interim analysis of the ENHANCE trial evaluating magrolimab in higher-risk MDS, given the need for treatment options. We will continue to monitor and report on the other magrolimab trials.
Importantly, while not every trial will be positive, our efforts at building a well-diversified portfolio gives us multiple opportunities to improve the lives of patients. We're excited about our momentum in making oncology and inflammation important contributors to our future and continue to make strong progress on delivering our key clinical catalysts for this year.
Beyond our near-term milestones, I'd also like to highlight our growing pipeline of early-stage inflammation assets, including our oral alpha 4 beta 7 and the progression of our IRAK4 inhibitor that had asserted into Phase 2, as well as the advancement of the BTLA agonist program from the MiroBio acquisition into Phase 1. We are excited by this differentiated inflammation pipeline and the potential to impact important gaps in the treatment of inflammatory diseases. Overall, we believe we have a very ambitious clinical portfolio that is well-diversified across indications and stage. We look forward to updating you as we progress through 2023.
With that I'll hand the call over to Andy. Andy?
