According to “ Five things to consider about referring patients for CAR-T cell therapy “ CAR-T cell therapy has been a breakthrough innovation in cancer care since its approval by the US Food and Drug Administration (FDA) in 2017. It has shown promising results for patients with certain types of advanced blood cancers. For hematological oncologists, the approval of CAR-T cell therapy in some indications may add another treatment option — making it important to understand how CAR-T cell therapy fits into the wider patient journey.
KYMRIAH® (tisagenlecleucel) Suspension for IV infusion, one type of CAR-T cell therapy, manufactured by Novartis Pharmaceuticals Corporation NYSE: NVS, has been assessed in the JULIET clinical study. An open-label, multicenter, single-arm trial conducted at 27 sites in 10 countries across North America, Europe, Australia, and Asia — and is FDA approved for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). Specifically, large B-cell lymphoma after two or more lines of systemic therapy including DLBCL not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. As with many cancer treatments, there are risks, and it is important to know that CAR-T cell therapies including Kymriah can have side effects that may be severe or life threatening, including cytokine release syndrome (CRS) and neurological toxicities (NT). In the JULIET clinical study, at 9.4 month follow-up, 74% of patients experienced CRS, with 23% experiencing grade 3 or higher CRS, and 58% experienced NT, with 18% experiencing grade 3 or higher NT. To mitigate the risks of these adverse events, Kymriah is available through a Risk Evaluation and Mitigation Strategy (REMS) program called the KYMRIAH REMS.
This program ensures the treatment centers and HCPs administering Kymriah are prepared to manage CRS and neurological toxicities. In follow up analyses of the JULIET clinical study, the Kymriah safety profile has remained consistent.1,3,4 The most common adverse reactions (incidence >20%) were CRS, infections-pathogen unspecified, diarrhea, nausea, pyrexia, fatigue, hypotension, edema, and headache.1 With the addition of CAR-T cell therapies as a treatment option for oncologists to consider for their patients with DLBCL, it is important to know who is eligible, when they should be referred, and where they can be treated. Here are five things to consider about CAR-T cell therapy for patients with DLBCL — and how oncologists can help make the most of this innovative treatment option for their patients.
- Unlike stem cell transplant (SCT), patients do not need to be in complete remission to receive CAR-T cell therapy
- CAR-T cell therapy may be an option for patients who have relapsed from SCT, or may otherwise not be eligible or fit for SCT
- Older patients with relapsed or refractory disease may still be eligible for and may benefit from CAR-T cell therapy
- Timely referrals are important to CAR-T cell therapy outcomes
- After referral of an eligible patient for CAR-T cell therapy, both the treatment center and the patient’s primary oncologist will contribute to their care
Avalon GloboCare Corp. (NASDAQ: AVCO) is a clinical-stage, vertically integrated, leading CellTech bio-developer with major prospects in immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. Avalon also provides strategic advisory and outsourcing services to facilitate and enhance its clients’ growth and development, as well as competitiveness in healthcare and CellTech industry markets.
In the first quarter of 2020, Avalon GloboCare (NASDAQ: AVCO) successfully completed a phase 1 first-in-human clinical study of AVA-001 in China for the treatment of relapsed refractory B cell acute lymphoblastic leukemia (R/R B-ALL). 90% of R/R B-ALL patients achieved complete remission with one dose and within one month of treatment, and then proceeded to a curative-intent allogeneic bone marrow transplant. Also there was minimal and well tolerated side effects with little neurotoxicity or cytokine release. This paradigm of bridging CAR-T cell therapy to bone marrow transplant creates a new horizon with potentially ground breaking commercial application for patients with relapsed/refractory B-ALL and other hematologic cancers.
So far in 2021 Avalon GloboCare (NASDAQ:AVCO) has advanced there research platform substantially by expanding a Co-Development program with MIT using CRISPR based genome editing to combat cancer metastasis. They also announced a collaboration with the University of Pittsburgh Medical Center for development of their FLASH-CAR™ RNA-based cellular therapies includes utilization of Avalon’s new Point-of-Care Modular Autonomous Processing System (PMAPsys™). First FLASH-CAR™ candidate, AVA-011, on-track for clinical study in B-cell lymphoblastic leukemia and non-Hodgkin’s lymphoma patients. The FLASH-CAR™ technology modifies patients’ T-cells and natural killer (NK) cells using a ribonucleic acid (RNA)-based platform rather than a viral vector, and is being co-developed with the Company’s strategic partner, Arbele Limited. The adaptable FLASH-CAR™ platform can be used to create personalized cell therapies from a patient’s own cells, as well as “off-the-shelf” cell therapies from a universal donor. By avoiding viral vectors and complicated bio-processing procedures, the FLASH-CAR™ technology significantly reduces manufacturing costs and development times, resulting in more affordable and potentially breakthrough therapies for cancer patients. Avalon’s innovative FLASH-CAR™ technology can be used to generate universal cell therapies that may allow for widespread patient accessibility enabling broader commercial adoption compared to currently available CAR-T cell therapies. Avalon’s first FLASH-CAR™ platform candidate, AVA-011, targets both CD19 and CD22 tumor antigens on cancer cells and is in development for patients with relapsed/refractory B-cell lymphoblastic leukemia and non-Hodgkin’s lymphoma.
“This is an important milestone in the clinical development and production of AVA-011 and other RNA-based FLASH-CAR™ candidates ahead of the start of our first-in-human clinical trials,” said David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare. “We are excited about our partnership on the PMAPsys™ with UPMC, which we believe will help accelerate the path to bringing our own and third-party cell therapies to market. We are working diligently to fast-track development and commercialization of our cellular immune-oncology therapeutic products, while providing the highest quality and safety standards for our patients.”
Avalaon GloboCare (NASDAQ:AVCO) is teaming up with some of the brightest minds in CAR-T and CRISP based technologies including Dr. Yen-Michael Hsu, M.D., Ph.D., Director of the Immunologic Monitoring and Cellular Products Laboratory at the UPMC Hillman Cancer Center and Dr. Shuguang Zhang at MIT’s Media La to rapidly develop potentially lifesaving technological advancements with major commercial applications. Recently some of the smartest money on Wall Street has been extremely bullish on this specific niche including Catherine Wood at ARK invest, in a recent interview she stated that her ARKG (ARK Genomic) ETF has the most potential upside over the next five years as the fund has been deploying billions to companies that produce or enable CRISPR, another Targeted Therapeutics. Over the past few weeks microcap stocks have been under more than usual pressure resulting in Avalon GloboCare NASDAQ (AVCO) to be trading at their 52 week low at just around S1.00 a share. I strongly believe Avalon’s pipe line along with a market cap of less than 100 million creates a highly asymmetric risk reward opportunity.