Thank you for holding. Good afternoon, and welcome to the ADC Therapeutics Zonologna SDA Approval Conference Call. At this time, all participants are on a listen only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that this call is being recorded at the company's At this time, I'd like to turn the call over to Amanda Hamilton, Investor Relations Manager and ADC Therapeutics.
Please proceed.
Thank you, operator. This afternoon, we issued a press release announcing the FDA approval of Blanca, which is now known as ZENLANTA. This release is available on the ADCT website at ir.adctherapeutics.com under the Press Releases section. On today's call are Chris Martin, Chief Executive Officer Jay Feingold, Chief Medical Officer and Jennifer Herron, Chief Commercial Officer. In addition, Jen Creel, our Chief Financial Officer, will join for the Q and A session.
As a reminder, this conference call may contain forward looking statements. Such statements are subject to risks and uncertainties. We refer you to the section titled Cautionary Statement Regarding Forward Looking Statements in our annual report on Form 20F filed with the U. S. Securities and Exchange Commission for further information on forward looking statements.
Such statements speak only as of the date of this conference call, and we expressly disclaim any obligation or undertaking to update these forward looking It is now my pleasure to pass the call over to our CEO, Chris Martin. Chris?
Thanks, Amanda, and thank you for joining us today. I'm truly delighted to be with you to discuss a Significant milestone for oncology patients and for ATC Therapeutics. Today, a month before our PDUFA date, I'm very pleased to say that the FDA granted accelerated approval for Lonka, brand name ZYNLONTA, for the treatment of adult patients With relapsed or refractory large B cell lymphoma after 2 or more lines of systemic therapy. In addition to accelerated approval for diffuse large B cell not otherwise specified, ZYNOLTA was also approved for DLBCL arising from low grade lymphoma And high grade B cell lymphoma with the latter being an important point of differentiation. Jay will discuss our clinical highlights a little later in the call.
ADC Therapeutics was founded on our strong commitment to improving the lines of patients with our next generation ADC technology. In March 2016, the first patient was dosed in our Phase 1 trial of ZYNOLTA. Just over 5 years later, we have received FDA accelerated approval. I would like to take this opportunity to thank each and every one of our dedicated colleagues for their tireless efforts to bring ZYNOLTA to patients. I would also like to thank our investigators, collaborators, and most importantly, the patients Who participated in the clinical trials and their families who helped us make this achievement possible.
As we celebrate our first product approval, We mark our evolution from an R and D company to a fully integrated commercial organization. Jennifer Heron, our Chief Commercial Officer, Has done a tremendous job in preparing the commercial team alongside our medical affairs team to ensure successful launch. Jennifer will share further details of our launch plan later in the call. I would now like to hand the call over to our Chief Medical Officer, Jay Feingold, who will review the clinical data supporting ZYNOLTA's approval. Jay?
Thank you, Chris. This is indeed a momentous day for the company and for the patients. As many of you know, I've been an oncologist for more than 30 years and have been involved in drug discovery and development for most of that time. While tremendous progress has been made treating hematologic malignancies, There remains a significant unmet medical need for patients not cured by first or subsequent lines of therapy. Today, I'm excited to be part of the team that is bringing ZERMUNTA to patients with relapsed refractory diffuse large B cell lymphoma, including those with very hard to treat forms of the disease.
ZYNOLTA is the 1st and only CD19 targeted antibody drug conjugate approved for the treatment of this indication. The data from the LOTUS-two trial establishes the significant activity of ZEMURTA as a monotherapy for these patients. And I'm very pleased that we have received a broad indication, including high grade B cell lymphoma. We believe That XERLYNXA has the potential to be the standard of care in fair line and later patients. We look forward to continuing our work to study ZERMONTA as part of combination modalities and in earlier lines of therapy.
ZERMONTA was granted accelerated approval under priority review Based on the LOTUS II trial, a single arm multicenter open label Phase II trial that enrolled a total of 145 patients With relapsedrefractory diffuse large B cell lymphoma, following at least two lines of prior systemic therapy. The trial included a broad spectrum of heavily pretreated patients with very difficult to treat disease, including patients with high grade B cell lymphoma. The trial also enrolled patients who never responded to first line of therapy and patients who did not respond to any prior line of therapy, as well as patients who have prior stem cell transplants and prior CAR T therapy. While a portion of patients are cured in first line treatment, Approximately 40% either have refractory disease or relapse. And of these patients, approximately 50% will require third line therapy.
This broad patient population is reflected in the LOTUS-two trial and represents the patients who remain in need of another treatment option. The overall response rate in the total patient population was 48% and an additional 15% had stable disease. It was also very encouraging to see compelling overall response rates even in the high risk category populations that I mentioned earlier and even in the older patients. For example, patients who never responded to first line therapy And while age is typically an indicator of treatment outcome, Solanta was equally efficacious and had similar safety profiles in patients older and younger 65. The median duration response to the data package for the BLA submission was 10.3 months.
Excuse me. As we continue to follow patients, this data has since matured and the median duration of response at the last analysis was 12.6 months for all responders and 13.4 months for patients who had a complete response. As expected, this in line to label contains important safety information. Notably, the label reflects the manageable safety profile of ZULRENZA with no black box warnings and no contraindications. You can see on the slide, the warnings and precautions as well as the most common adverse events that pool safety population of our Phase 1 and Phase 2 trials of 2 19% of patients in the Phase 2 trial discontinued through treatment related adverse events.
To put this safety information in perspective, it's important to consider the heavily pretreated patient population in the Phase 2 trial With the median number of guidelines of therapy was 3. We believe the recommended monitoring and management guidelines are clear and straightforward And that physicians will be able to adequately manage adverse events. Samantha offers a truly differentiated treatment option for relapsed refractory diffuse large B cell lymphoma patients. We also think this first approval is just the beginning. As the slide shows, we continue to explore XERONA's potential in additional promising combinations, early in lines of therapy and new histologies.
With that, I will turn the call over to Jennifer to discuss the highlights of the commercial launch.
Thank you, Jay. I'm excited to be on this call today to provide an update on the preparations we have made to support a successful launch of ZYNLANTA. Before I get into the specifics of the ZYNOLTA launch plan, I would like to reiterate that relapsedrefractory DLBCL remains an area of Significant unmet medical need, especially in the 3rd line plus setting, where patients are heavily pretreated and often have poor prognostic factors, creating unique challenges for treating physicians. One of the key aspects of the LOTUS-two trial is the broad inclusion of these relapsed refractory patients, including patients who did not respond to first line or any prior lines of therapy, Patients who failed CAR T therapy or stem cell transplant and patients with high grade B cell lymphoma, including those with double and Triple Hit Genetics. These difficult to treat patients included in the LOTUS-two trial and therefore in the ZENLONTA label are representative of an oncologist's everyday practice population.
As Chris mentioned, an important point of differentiation for ZYNOLTA is the broad indication in 3rd line plus DLBCL, including DLBCL not otherwise specified, DLBCL arising from low grade lymphoma and high grade B cell lymphoma, as well as both transplant eligible and ineligible patients. In terms of the initial market opportunity, we estimate approximately 10,500 3rd line plus DLBCL patients in the U. S. And EU5 for a 3rd line plus market opportunity in excess of $1,000,000,000 And importantly, we have a number of ongoing and planned trials to potentially expand into additional histologies And earlier lines of therapy representing additional business opportunities. With FDA approval in hand, Our team will deliver on 3 launch imperatives to ensure a successful ZENLONTA launch.
First, we will effectively communicate the differentiated profile
of ZENLONTA.
Its significant single agent activity file of ZENLONTA. It's significant single agent activity across a real world patient population highlighted by our broad indication. With nearly half of the LOTUS-two patients responding to ZENLONTA, it's important to note that patient response to therapy was seen at a median of only 41 days. Uniquely, ZINLANTA is delivered in a convenient 30 minute IV infusion every 21 days. Our second launch imperative is to ensure a positive first experience for physicians and patients to support trial and repeat use through frequent engagement and education as we established ZYNOLTA as the 3rd line plus standard of care.
And finally, to ensure that any patient who may benefit from ZENLONTA has the opportunity, we have a robust plan to support open access, We are confident in our ability to establish ZYNLONTA as a third line plus standard of care and encouraged by our insights from extensive market research and our ongoing interactions with both academic and community thought leaders. Despite recently approved combinations, physicians still see significant areas of unmet medical need among their treatment choices. The ZYNOLTA product profile was very well received by treating Hemox, where physicians indicated that the LOTUS II clinical trial population uniquely reflected their real world practice to include a broad population of relapsed refractory patients, including heavily pretreated patients and patients with difficult to treat disease. Physicians were impressed With a robust single agent efficacy, manageable side effect profile and convenient 30 minute infusion. This research also indicated a high willingness would combine with other agents for application in earlier lines of therapy.
We have built a world class commercial team of seasoned oncology professionals to drive the launch of ZYNLATA across marketing, sales and market access. The sales team has an average of 13 years of oncology experience and an average of 8 years of specific hematology expertise. Each hematology therapeutic specialist has a strong local network across their geography, has completed their business planning And with the final USPI is perfecting the communication of the ZYNOLTA value proposition for prescribers and other healthcare providers. Our market access team is equally impressive, including a field based payer team with an average of 22 years of oncology experience and an average of 8 years of specific expertise in hematology. Our 70 plus customer facing team covers Over 90% of the total DLBCL opportunity and we are confident in our plans, in our seasoned commercial organization and our ability to Established Enlanta as the 3rd line plus standard of care.
While we recognize the challenges of launching in a COVID environment, we have prepared for this reality and the team has already begun executing this hybrid model as they have introduced ADC Therapeutics to the hematology oncology community. Customer engagement has included and will include a range of options from purely digital to face to face interactions, And our teams are trained and well positioned to engage all of our customers with an individual approach, while respecting local and institutional guidelines. We have developed multi channel communications to ensure that all key audiences, physicians, nurses, office managers, payers and patients Receive the necessary information and support to ensure access to and safe administration of ZYNOLTA. Seamless distribution, patient access and support services are all critical to ensuring that every patient who may benefit from ZYNLATA has the opportunity to receive As soon as possible. To this end, we are on track to make ZYNOLTA commercially available next week.
From a distribution perspective, we have commercial to support the launch and beyond. 3rd party logistics are fully in place and our specialty distributors are ready to fill orders. In terms of pricing, the wholesale acquisition cost or WACC for a 10 milligram vial of ZYNLATA is $23,500 which reflects the differentiated value of ZENLONTA and is consistent with payer stakeholder expectations reflected in our extensive market research. Based on the approved dosing regimen for ZYNLATA, it is important to consider that like many oncology agents, ZYNLATA uses weight based dosing. As a result, some patients will require 2 vials for each of the first two consolidation cycles.
In the LOTUS II trial, Patients received a median of 4.5 cycles of ZYNOLTA. Our account directors and MSLs have been actively engaging with payers and other key access stakeholders for many months now discussing the unmet medical needs in relapsed refractory DLBCL. In addition, our MSLs have been responding to medical questions about the LOTUS-two trial data. From these encouraging discussions, we expect ZYNOLTA to be readily covered We are pleased to offer Advancing Patient Support, our comprehensive patient assistance program. The Advancing Patient Support Program includes access and insurance coverage support, reimbursement and financial support and nursing support to address and Remove any potential barriers for patients and ensure that any patient who may benefit from ZENLANTA treatment has the opportunity to do so.
In summary, we are well prepared and very excited to launch ZENLANTA. We have carefully laid the necessary Groundwork leading up to this day. We have an exceptional team of top industry talent and a truly differentiated product, and we are confident in our ability to establish NINLONTA as the 3rd line plus standard of care. With that, I will turn the call back to Chris for closing remarks. Chris?
Thanks, Jennifer, and thank you, Jay. I'm super excited about the future of AGC Therapeutics As we enter this next phase of transformation and growth, the company is built on a strong scientific foundation based on our proprietary next generation ADC Technology, which has been validated by our 1st FDA accelerated approval of ZYNLONTA, which is the first ever approval We have 5 assets in ongoing clinical development and another 7 preclinical research programs in both hematological and solid tumor indications. And most importantly, a fantastic team with the ambition to transform the lives of patients. I'm
proud of
our achievements to date and look forward to updating you on our progress. We'll now open our call for questions. Operator?
We will now take any questions you may You have a question from the line of Matthew Harrison with Morgan Stanley. Please go ahead. And Matthew, your line is open. And again, Matthew, your line is open. And there are no questions in queue at this time.
I will now turn the call back to Chris.
Thank you, operator, and thank you everybody for listening to this call. And we'll be happy to talk to you and update you in future calls. So at the end of this very exciting day, I'd just like to say thank you, good evening, and have a good weekend. Take care. Goodbye.