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.

On September 21, 2022 Novocure (NASDAQ: NVCR) reported the creation of its U.S. CNS (central nervous system) Cancers Franchise (Press release, NovoCure, SEP 21, 2022, View Source [SID1234621318]). This new organization will add resources, streamline decision-making and improve coordination across Novocure’s U.S. CNS business, and is intended to renew focus on growth in Novocure’s glioblastoma (GBM) business .

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"Frank has been a tremendously successful business leader throughout his tenure at Novocure, always driving teams to produce impactful results. I look forward to Frank’s dedicated focus on GBM and CNS cancers and to our company’s continued pursuit of extending survival in some of the most aggressive forms of cancer."

Frank Leonard, who served as Novocure’s Chief Development Officer since 2020, is named President, CNS Cancers U.S., effective September 19, 2022. Mr. Leonard will be responsible for the entirety of the U.S. CNS business including U.S. GBM Sales and Marketing, Regional Marketing, Learning & Development, Maxpoint, Government Affairs and U.S. CNS Medical teams. Pritesh Shah, Novocure’s Chief Commercial Officer, will retain responsibility for global commercial strategy and brand management, the EMEA and APAC regions and future indications.

"I am very pleased with the creation of the U.S. CNS Cancers Franchise, specifically focused on delivering Tumor Treating Fields therapy to additional GBM patients," said Asaf Danziger, Novocure’s Chief Executive Officer. "Frank has been a tremendously successful business leader throughout his tenure at Novocure, always driving teams to produce impactful results. I look forward to Frank’s dedicated focus on GBM and CNS cancers and to our company’s continued pursuit of extending survival in some of the most aggressive forms of cancer."