On September 21, 2022 CTI BioPharma Corp. (NASDAQ: CTIC) reported two poster presentations from the Company’s pacritinib program at the Society of Hematologic Oncology (SOHO) Tenth Annual Meeting, to be held in Houston, Texas and virtually September 28 – October 1, 2022 (Press release, CTI BioPharma, SEP 21, 2022, View Source [SID1234621323]).

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A new data analysis from the Phase 3 PERSIST-2 trial and an in vitro analysis of pacritinib, a novel JAK2/IRAK1 inhibitor approved by the U.S. FDA for patients with myelofibrosis and a platelet count below 50 x 109/L, will highlight pacritinib’s impact on anemia and inhibition of Activin A receptor type 1 (ACVR1).

"Treatment with pacritinb at the approved dose of 200 mg twice daily (BID) led to improvements in transfusion independence and anemia when compared to best available therapy (BAT) in patients treated on the PERSIST-2 Phase 3 study," said Dr. Stephen Oh, MD, PhD, Associate Professor of Medicine, Hematology Division at Washington University School of Medicine in St. Louis. "I am encouraged by these data, given the limited options to address anemia in myelofibrosis, especially high-risk patients with cytopenias who frequently require blood transfusions. I look forward to further investigation of pacritinib’s potential to alleviate anemia and related symptoms in this patient population."

"We are pleased to report that pacritinib is a highly potent inhibitor of ACVR1. This inhibition is thought to lead to improvements in blood transfusion requirements and anemia in patients with cytopenic myelofibrosis," said Adam Craig, MD, PhD, President and Chief Executive Officer of CTI BioPharma. "The data presented at SOHO 2022 support our belief that pacritinib is a simple, safe and effective JAK2 inhibitor. We plan to present additional data on pacritinib’s anemia benefit at a medical meeting later this year."

Presentation materials will be available at ctibiopharma.com.

Retrospective Analysis of Anemia Benefit of Pacritinib from the PERSIST-2 Trial

Abstract Number: MPN-145
Session Name: Poster Session
Session Date: Wednesday, September 28
Presentation Time: 5:05-6:30 p.m. CDT (06:05-7:30 p.m. EDT)
Presenter: Dr. Stephen Oh

Pacritinib is a novel JAK2/IRAK1 inhibitor approved by the U.S. Food and Drug Administration (FDA) for patients with myelofibrosis and severe thrombocytopenia (platelet count <50 x 109/L). Previous clinical trials have noted improvements in spleen volume and symptom scores, as well as improvement in anemia and a decline in transfusion burden. A retrospective analysis of the Phase 3 PERSIST-2 trial was conducted to further assess pacritinib’s impact on anemia, and an in vitro analysis was performed to explore pacritinib’s inhibition of Activin A receptor type 1 (ACVR1; also known as activin receptor-like kinase 2 [ALK2]).

On duplicate assays, pacritinib was shown to be a more potent inhibitor of ACVR1 compared to momelotinib, with a half maximal inhibitory concentration (IC50) of 10.8 and 22.6 nM versus34.9 and 70.2 nM, respectively. The percentage of patients who achieved transfusion independence over any 12-week intervals through week 24 was greater on pacritinib 200 mg twice daily than best available therapy (27% vs 7%), among evaluable non-transfusion independent patients (defined as any red blood cell transfusions in 90 days prior to the first dose or a baseline hemoglobin <8 g/dL). These data suggest an important role for pacritinib in addressing anemia in patients with myelofibrosis.

Retrospective Comparison of Patient Outcomes on Pacritinib Versus Ruxolitinib in Patients with Myelofibrosis (MF) and Thrombocytopenia (encore)

Abstract Number: MPN-141
Session Name: Poster Session
Session Date: Wednesday, September 28
Presentation Time: 5:05-6:30 p.m. CDT (06:05-7:30 p.m. EDT)
Presenter: Dr. Prithviraj Bose

Pacritinib is a novel JAK2/IRAK1 inhibitor approved by the U.S. FDA for patients with myelofibrosis and severe thrombocytopenia (platelet count <50 x 109/L). Unlike the JAK 1/2 inhibitor ruxolitinib, which must be dose-reduced or held in patients with thrombocytopenia, pacritinib has been studied at full dose regardless of platelet count. This retrospective analysis reported on the outcomes in patients treated with pacritinib versus ruxolitinib in the Phase 3 PERSIST-2 study. Patients were randomized 1:1:1 to pacritinib 200 mg BID, pacritinib 400 mg once daily (QD) or BAT, with 45 percent of patients on BAT receiving ruxolitinib.

Results show that pacritinib, administered at the full dose of 200 mg BID, yielded higher response rates and a similar safety profile compared to lower-dose ruxolitinib in patients with myelofibrosis who have moderate or severe thrombocytopenia.

About VONJO (pacritinib)
Pacritinib is an oral kinase inhibitor with activity against wild type Janus Associated Kinase 2 (JAK2), mutant JAK2V617F form and FMS-like tyrosine kinase 3 (FLT3), which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Myelofibrosis is often associated with dysregulated JAK2 signaling. Pacritinib has higher inhibitory activity for JAK2 over other family members, JAK3 and TYK2. At clinically relevant concentrations, pacritinib does not inhibit JAK1. Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1), the clinical relevance of which is unknown.

VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important VONJO Safety Information
Hemorrhage:
Serious (11%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <100 × 109/L. Serious (13%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <50 × 109/L. Grade ≥3 bleeding events (defined as requiring transfusion or invasive intervention) occurred in 15% of patients treated with VONJO compared to 7% of patients treated on the control arm. Due to hemorrhage, VONJO dose reductions, dose interruptions, or permanent discontinuations occurred in 3%, 3%, and 5% of patients, respectively.

Avoid use of VONJO in patients with active bleeding and hold VONJO seven days prior to any planned surgical or invasive procedures. Assess platelet counts periodically, as clinically indicated. Manage hemorrhage using treatment interruption and medical intervention.

Diarrhea:
VONJO causes diarrhea in approximately 48% of patients compared to 15% of patients treated on the control arm. The median time to resolution in VONJO-treated patients was two weeks. The incidence of reported diarrhea decreased over time, with 41% of patients reporting diarrhea in the first eight weeks of treatment, 15% in weeks 8 through 16, and 8% in weeks 16 through 24. Diarrhea resulted in treatment interruption in 3% of VONJO-treated patients. None of the VONJO-treated patients reported diarrhea that resulted in treatment discontinuation. Serious diarrhea adverse reactions occurred in 2% of patients treated with VONJO compared to no such adverse reactions in patients in the control arm.

Control pre-existing diarrhea before starting VONJO treatment. Manage diarrhea with antidiarrheal medications, fluid replacement, and dose modification. Treat diarrhea with antidiarrheal medications promptly at the first onset of symptoms. Interrupt or reduce VONJO dose in patients with significant diarrhea despite optimal supportive care.

Thrombocytopenia:
VONJO can cause worsening thrombocytopenia. VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre-existing moderate to severe thrombocytopenia (platelet count <100 × 109/L). VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre-existing severe thrombocytopenia (platelet count <50 × 109/L).

Monitor platelet count prior to VONJO treatment and as clinically indicated during treatment. Interrupt VONJO in patients with clinically significant worsening of thrombocytopenia that lasts for more than seven days. Restart VONJO at 50% of the last given dose once the toxicity has resolved. If toxicity recurs hold VONJO. Restart VONJO at 50% of the last given dose once the toxicity has resolved.

Prolonged QT interval:
VONJO can cause prolongation of the QTc interval. QTc prolongation of >500 msec was higher in VONJO-treated patients than in patients in the control arm (1.4% vs 1%). QTc increase from baseline by 60 msec or higher was greater in VONJO-treated patients than in control arm patients (1.9% vs 1%). Adverse reactions of QTc prolongation were reported for 3.8% of VONJO-treated patients and 2% of control arm patients. No cases of torsades de pointes were reported.

Avoid use of VONJO in patients with a baseline QTc of >480 msec. Avoid use of drugs with significant potential for QTc prolongation in combination with VONJO. Correct hypokalemia prior to and during VONJO treatment. Manage QTc prolongation using VONJO interruption and electrolyte management.

Major Adverse Cardiac Events (MACE):
Another JAK)-inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with VONJO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

Thrombosis:
Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated.

Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately.

Secondary Malignancies:
Another JAK-inhibitor has increased the risk of lymphoma and other malignancies, excluding non-melanoma skin cancer (NMSC) (compared to those treated with TNF blockers), in patients with rheumatoid arthritis, a condition for which VONJO is not indicated. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with VONJO, particularly in patients with a known malignancy (other than a successfully-treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.

Risk of Infection:
Another JAK-inhibitor has increased the risk of serious infections compared to best available therapy (BAT) in patients with myeloproliferative neoplasms. Serious bacterial, mycobacterial, fungal and viral infections may occur in patients treated with VONJO. Delay starting therapy with VONJO until active serious infections have resolved. Observe patients receiving VONJO for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines.

Interactions with CYP3A4 Inhibitors or Inducers:
Co-administration of VONJO with strong CYP3A4 inhibitors or inducers is contraindicated. Avoid concomitant use of VONJO with moderate CYP3A4 inhibitors or inducers.

Drug interruptions due to an adverse reaction occurred in 27% patients who received VONJO 200 mg twice daily compared to 10% of patients treated with BAT. Dosage reductions due to an adverse reaction occurred in 12% of patients who received VONJO 200 mg twice daily compared to 7% of patients treated with BAT. Permanent discontinuation due to an adverse reaction occurred in 15% of patients receiving VONJO 200 mg twice daily compared to 12% of patients treated with BAT.

Please visit View Source for full Prescribing Information and the Medication Guide.

About Myelofibrosis
Myelofibrosis is bone marrow cancer that results in formation of fibrous scar tissue and can lead to thrombocytopenia and anemia, weakness, fatigue and an enlarged spleen and liver. Within the United States, there are approximately 21,000 patients with myelofibrosis, 7,000 of which have severe thrombocytopenia (defined as blood platelet counts of less than 50 x109/L). Severe thrombocytopenia is associated with poor survival and high symptom burden and can occur as a result of disease progression or from drug toxicity with other JAK2 inhibitors, such as JAKAFI and INREBIC.

On September 21, 2022 Global Coalition for Adaptive Research (GCAR), Sponsor of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) master protocol, reported that regorafenib has completed enrollment and follow-up in GBM AGILE (Press release, Global Coalition for Adaptive Research, SEP 21, 2022, View Source [SID1234621322]). Enrollment for the arm was stopped after an interim analysis showed a low probability of sufficient improvement in overall survival as compared with randomized controls.

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Regorafenib was being evaluated in GBM AGILE for efficacy in patients with recurrent glioblastoma and in patients with newly diagnosed MGMT unmethylated glioblastoma. Regorafenib is an oral multikinase inhibitor that potently blocks multiple protein kinases, including kinases involved in oncogenesis, tumor angiogenesis, and tumor immunity. Preclinical data and preliminary efficacy in recurrent glioblastoma compared to lomustine in the "REGOMA" study (a randomized multi-institutional investigator-sponsored phase 2 trial) supported the late-stage evaluation of regorafenib in GBM AGILE.

GBM AGILE is an international, innovative platform trial designed to identify effective therapies more rapidly for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design. Regorafenib was the first drug to be evaluated in GBM AGILE. It was being studied as a monotherapy vs. lomustine in patients with recurrent glioblastoma, and vs. adjuvant temozolomide in patients with MGMT-unmethylated newly diagnosed glioblastoma following concurrent radiotherapy and temozolomide. The regorafenib investigational arm was concurrently and adaptively randomized against other investigational arms (as well as the internal controls) that GBM AGILE continues to evaluate. The regorafenib arm of GBM AGILE is being co-led by Principal Investigators Dr. Patrick Wen, MD, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and Dr. Andrew Lassman, MD, Chief of the Neuro-Oncology Division in the Department of Neurology at New York-Presbyterian/Columbia University Irving Medical Center.

"Glioblastoma is a cancer of high unmet need that has proven to be notoriously difficult to treat. GBM AGILE was created in response to that unmet need, serving to efficiently evaluate multiple therapies concurrently with the goal of efficiently identifying more effective treatments for patients with glioblastoma," said Dr. Timothy Cloughesy, MD, Global Principal Investigator of GBM AGILE, Chief Medical Officer for GCAR, and Director, UCLA Neuro-Oncology Program. "GBM AGILE leadership, particularly investigational arm Principal Investigators, Dr. Patrick Wen and Dr. Andrew Lassman, are reviewing the regorafenib data, which may produce signals for future development considerations, and will share final results in the coming months."

"GBM AGILE is a critical and rigorous mechanism for us to quickly evaluate investigational drugs in a well-controlled, randomized setting," said Dr. Andrew Lassman, who also serves as Associate Director of Clinical Trials for the Herbert Irving Comprehensive Cancer Center and Associate Dean of Clinical Trials at Columbia University’s Vagelos College of Physicians & Surgeons. "Obviously, we hoped that GBM AGILE would confirm and extend the efficacy of regorafenib suggested by earlier studies. However, the results also show that GBM AGILE functions as designed so that more patients can be allocated to other treatments that may be more efficacious with resources directed to these alternatives."

"While we are disappointed that the interim results from the regorafenib arm in GBM AGILE did not support graduation to a second stage in GBM AGILE and subsequent regulatory approval, we are pleased to report that GBM AGILE is operating as intended. The trial provides a platform for "learning" about a drug’s performance in an efficient, cost-effective, and well-controlled environment," said Dr. Patrick Wen. "We are sincerely grateful for the patients, their families, and the clinical research teams who have contributed to the evaluation of regorafenib in GBM AGILE."

The GBM AGILE design and infrastructure constitutes a more efficient and cost-effective approach to testing new therapies for GBM, with the purpose of potentially identifying and then bringing new beneficial treatments to patients sooner. Since launching in July 2019, GBM AGILE has screened over 1300 patients and is open at more than 45 sites in Canada, US, and Europe with plans to open additional sites in Australia and Europe.

On September 21, 2022 US Medical Innovations, LLC (USMI), a subsidiary of US Patent Innovations, LLC, reported it has secured a $10.2 million private placement deal from multiple sources including existing partners and new investors (Press release, US Medical Innovations, SEP 21, 2022, View Source [SID1234621321]). USMI will be using these funds to ramp-up manufacturing of its newly-released Canady Plasma XL-1000 SMART Electrosurgical Generator (XL-1000) and support the development and release of its Canady Helios Cold Plasma Generator (CHCP) and robotic delivery system for the selective treatment of cancer.

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CEO Dr. Jerome Canady commented, "We are pleased to have closed this round of private financing at such a critical time in our development efforts. We see this investment by seasoned investors as a strong vote of confidence in our mission to develop disruptive technology that will change the landscape of electrosurgery and cancer therapy."

In April 2021, USMI completed the first FDA-IDE-approved clinical trial to evaluate cold atmospheric plasma (CHCP) for the treatment of cancer and is preparing for the launch of several Phase II multi-center international trials starting in Q/1 2023. The Company has recently released its new XL-1000 featuring Canady Hybrid Plasma Technology, a high-definition touchscreen, built-in surgical Apps, and a variety of safety and security features. Hybrid Plasma electrosurgery technology is used in more traditional surgeries such as hip and knee replacements.

Dr. Canady continued, "This investment, along with our additional sales revenue will allow us to continue to develop and refine our Cold Plasma technology for treating cancer as well as progress with our strategic plans for a 2023 IPO."

On September 21, 2022 AccessHope, LLC, a company that provides cancer expertise to employers who offer employer sponsored insurance programs, payers, and other health and wellness organizations, reported a new foundational collaboration with Fred Hutchinson Cancer Center (Fred Hutch) that extends the organization’s reach across key geographic regions of the United States, allowing more people living with complex cancers to access specialized cancer expertise with the aim of improving their cancer outcomes (Press release, Fred Hutchinson Cancer Research Center, SEP 21, 2022, View Source [SID1234621320]).

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Fred Hutch becomes AccessHope’s fifth collaboration with a National Cancer Institute (NCI)-Designated Comprehensive Cancer Center, a selective list that has grown since AccessHope was first founded and launched by City of Hope. Through the new collaboration, cancer specialists from Fred Hutch will provide specialized cancer expertise for AccessHope’s core services: Accountable Precision Oncology, Expert Advisory Review and Cancer Support Team.

"This collaboration helps further our goal at AccessHope of ensuring that cancer expertise is accessible to everyone, no matter where they live," said Mark Stadler, Chief Executive Officer of AccessHope. "Fred Hutch’s deep expertise, and the organization’s research in precision medicine to inform individualized cancer treatment recommendations, make the organization an incredibly valuable partner to us and to those who benefit from their deep bench of experts."

"AccessHope’s relevance to employers continues to grow as our national footprint expands. Cancer is now the leading driver of healthcare costs to employers1. At the same time, they’re looking for solutions to issues like health equity and affordability," said Harlan Levine, M.D., chair of the board for AccessHope. "AccessHope was founded to meet these top-of-mind concerns, providing needed support for employees and family members with cancer, and now, with the addition of Fred Hutch as a foundational partner, we are better positioned to serve plan members and their treating oncologists in the Northwest; we are honored to have them join us."

The collaboration between AccessHope and Fred Hutch will help inform plan members and their treating oncologists of the latest cancer research and personalized treatments.

"Ensuring that anyone who is facing a cancer diagnosis has access to leading-edge cancer care is paramount to everything we do at Fred Hutch," explained Tom Purcell, MD, MBA, Chief Medical Officer, Fred Hutchinson Cancer Center. "Entering into this collaboration with AccessHope enhances that goal. Collaborating with employers and payers involved with AccessHope, Fred Hutch physicians will play a critical role in supporting patients in our region and across the country through sharing key insights and knowledge that will help inform treatment plans, clinical trial opportunities and improve overall outcomes for cancer patients."

Fred Hutch is the only National Cancer Institute-Designated Cancer Center in Washington and brings together leading research teams and cancer specialists who translate science discovery into leading-edge cancer treatments. The organization provides every patient with an individualized care plan and is a leader in developing and offering access to groundbreaking clinical trials and immunotherapy.

Patients who receive care at an NCI-Designated Cancer Center or National Comprehensive Cancer Network facility have significantly better outcomes, including improved long-term survival and strengthened treatment guideline adherence. Yet, patients who do not receive treatment at one of these elite facilities have less access to insights on the latest breakthrough medications and targeted therapies. AccessHope’s ability to connect patients to remote cancer support services aims to extend oncology expertise across the United States, in every state and ZIP code, reducing health disparities while allowing plan members to stay close to home, supported by their families and under the care of their local oncologist.

AccessHope serves approximately 3.5 million plan members who have its cancer support services through more than 80 employers including 22 of the Fortune 500, and collaborative relationships with a growing number of health plans, third-party administrators, health care platforms, consumer-driven pharmacy benefit managers and health care services companies.

To learn more about AccessHope and its services, visit myaccesshope.org. To learn more about Fred Hutchinson Cancer Center, visit www.fredhutch.org.

On September 21, 2022 ADC Therapeutics SA (NYSE: ADCT) reported that ZYNLONTA (loncastuximab tesirine-lpyl) and camidanlumab tesirine (Cami) abstracts have been accepted for presentation at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2022), which will be held in Houston, Texas from September 28–October 1, 2022 (Press release, ADC Therapeutics, SEP 21, 2022, View Source [SID1234621319]).

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"We are looking forward to sharing the encouraging initial safety run-in results from our LOTIS-5 Phase 3 clinical trial evaluating ZYNLONTA in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma at SOHO 2022," said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. "This is one of several clinical studies of ZYNLONTA in combination with other drugs intended to evaluate ZYNLONTA in earlier lines of treatment. "

LOTIS-5 Initial Safety Run-In Results

LOTIS-5 is a Phase 3, randomized, open‐label, two‐part, two‐arm, multicenter study of loncastuximab tesirine in combination with rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Twenty patients were enrolled in part 1 in a nonrandomized safety run‐in. In part 2, approximately 330 patients will be randomized 1:1 to receive Lonca‐R or rituximab‐gemcitabine‐oxaliplatin (R‐GemOx).

The 20 patients in the safety run‐in were a median age of 74.5 years (range 35‐93) and received a median of 1 previous therapy (range 1‐6). As of the February 28, 2022, data cutoff:

The overall response rate by central review was 15/20 (75%). A total of 8/20 (40%) and 7/20 (35%) patients attained complete response and partial response, respectively.
The most common all‐grade TEAEs, regardless of the relationship to the study treatment, were rash (5 [25%]), fatigue (4 [20%]), and increased gamma-glutamyl transferase (4 [20%]). The most common grade ≥3 TEAEs were increased gamma-glutamyl transferase (3 [15%]), increased alanine aminotransferase (2 [10%]), and neutropenia (2 [10%]).
These data will be presented in the following poster:

Initial Safety Run‐In Results of the Phase 3 LOTIS‐5 Trial: Novel Combination of Loncastuximab Tesirine With Rituximab (Lonca‐R) Versus Immunochemotherapy in Patients With R/R DLBCL
Poster Number: ABCL-320

Details of ADC Therapeutics’ other poster presentations:

A Phase 2, Open-Label Study of Loncastuximab Tesirine in Combination with Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients with Diffuse Large B-cell Lymphoma (DLBCL) (LOTIS-9) (Encore data, first time as presentation)
Poster Number: ABCL-272

Health-Related Quality of Life and Tolerability in Patients With/Without Skin Toxicity During Loncastuximab Tesirine Treatment in a Phase 2 Clinical Trial (LOTIS-2)
Poster Number: ABCL-316

Long-term survival projections of loncastuximab tesirine-treated patients in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (Encore data, first time as presentation)
Poster Number: ABCL-334

Camidanlumab Tesirine: Updated Efficacy and Safety in an Open-Label, Multicenter, Phase 2 Study of Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL) (Encore)
Poster Number: HL-339

All posters will be presented on Wednesday, September 28 from 5:05 to 6:30 p.m. CT in Ballroom of Americas on Level 2 of the Hilton-Americas Houston. Posters will remain in the poster hall for viewing throughout the day on Thursday and Friday. Online access to posters for registered attendees will begin on Thursday, September 29.

Details of ADC Therapeutics’ oral presentation:

Camidanlumab Tesirine: Updated Efficacy and Safety in an Open-Label, Multicenter, Phase 2 Study of Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL) (Encore)
Date and Time: Friday, September 30, 5:48-5:58 p.m. CT
Location: Grand Ballroom G-L, 4th floor
Presenter: Alex Herrera, MD, City of Hope, Duarte, California, USA
Session XII: Hodgkin Lymphoma

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.