CARVYKTI® (ciltacabtagene autoleucel) was Awarded the Johnson Medal

Carvykti^®: A Personalized Medicine Delivered Through a One-Time Infusion

CARVYKTI® has been recognized with the Johnson Medal, which honors excellence in research and development within Johnson & Johnson. This award acknowledges the groundbreaking work done by the team in developing CARVYKTI®, the first and only BCMA-targeted therapy approved for treating patients with multiple myeloma as early as their first relapse.

About Johnson Medal

The Johnson Medal is the most prestigious company-wide honor awarded for excellence in research and development. Named after the late company president Robert Wood Johnson II, the medal was established in 1960, just three years prior to his retirement. Each year, a winning team is selected by a confidential executive committee based on quality criteria and the commercial success of their product or research. The Johnson Medal was first awarded to employee teams starting in 1978.

The Johnson Medal celebrates scientists who are dedicated to pushing the boundaries of science through cutting-edge research and transformative healthcare solutions. This recognition not only highlights individual and team achievements but also underscores the company’s commitment to innovation and excellence in the field of healthcare. The award serves as an inspiration for ongoing advancements in research and development, fostering a culture of scientific inquiry and achievement within the organization.

About CARVYKTI®

CARVYKTI^® is a treatment used for adult patients who have multiple myeloma. On September 27, Johnson & Johnson (NYSE: JNJ) announced significant long-term results from the Phase 3 CARTITUDE-4 study, demonstrating that a single infusion of CARVYKTI® (ciltacabtagene autoleucel) significantly extends overall survival (OS) in patients with relapsed or lenalidomide-refractory multiple myeloma.

The study was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.

Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma | NEJM

Authors: Jesús San-Miguel, Binod Dhakal, Kwee Yong, Andrew Spencer, Sébastien Anguille, María-Victoria Mateos, Carlos Fernández de Larrea, Joaquín Martínez-López, Philippe Moreau, Cyrille Touzeau, Xavier Leleu, Irit Avivi, Michele Cavo, Tadao Ishida, Seok Jin Kim, Wilfried Roeloffzen, Niels W.C.J. van de Donk, Dominik Dytfeld, Surbhi Sidana, Luciano J. Costa, Albert Oriol, Rakesh Popat, Abdullah M. Khan, Yaël C. Cohen, P. Joy Ho, D.Phil., James Griffin, Nikoletta Lendvai, Carolina Lonardi, Ana Slaughter, Jordan M. Schecter, Carolyn C. Jackson, Kaitlyn Connors,  Katherine Li, Enrique Zudaire, Diana Chen, Jane Gilbert, Tzu-min Yeh,  Sarah Nagle, Erika Florendo, Lida Pacaud, Nitin Patel, Simon J. Harrison, Hermann Einsele,

This groundbreaking therapy is now recognized as the first and only cell therapy to improve OS compared to standard therapies for patients who have received at least one prior line of treatment, including a proteasome inhibitor.

“At Johnson & Johnson, we remain committed to addressing unmet need through the development of innovative treatments for patients and healthcare providers, and we look forward to submitting these results to local health authorities worldwide.” – said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Innovative Medicine, Johnson & Johnson.

In February 2022, CARVYKTI^® (cilta-cel) received FDA approval for adult patients who have received at least one prior line of therapy, which must include a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide. This approval followed a unanimous recommendation (11 to 0) from the FDA Oncologic Drugs Advisory Committee (ODAC).

“This approval is a testament to our innovative science and galvanizes our efforts to provide new options that will improve outcomes for patients and give hope to them and their families.” – Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. 

In addition to the U.S. approvals, the European Medicines Agency (EMA) also approved a Type II variation for CARVYKTI® in May 2022, allowing its use for adults with relapsed and refractory multiple myeloma who have received at least one prior therapy that included an immunomodulatory agent and a proteasome inhibitor, have shown disease progression on their last therapy, and are refractory to lenalidomide. Furthermore, in September 2022, Japan’s Ministry of Health, Labour and Welfare approved CARVYKTI® for similar indications in patients with specific treatment histories.

Key Findings from the CARTITUDE-4 Study

The CARTITUDE-4 study evaluated CARVYKTI® against standard therapies, including pomalidomide, bortezomib, and dexamethasone (PVd), or daratumumab, pomalidomide, and dexamethasone (DPd). Key findings include:

• Overall Survival: At a median follow-up of approximately three years (34 months), CARVYKTI® reduced the risk of death by 45% compared to standard therapies. The median OS was not reached for either group, indicating a significant survival benefit for patients receiving CARVYKTI®.
• Survival Rates: At 30 months, OS rates were 76% for patients treated with CARVYKTI® compared to 64% for those receiving standard therapies.
• Progression-Free Survival: Median progression-free survival (PFS) was not reached for CARVYKTI® patients, while it was 11.79 months for those on standard therapies.
• Response Rates: Patients receiving CARVYKTI® achieved a 77% complete response or better and an 85% overall response rate. Additionally, 62% of these patients demonstrated minimal residual disease (MRD) negativity at the 10^-5 level.

“To compare, other drugs to date that have been approved [for multiple myeloma] were in the neighborhood of a 30%. Most of them have been constantly on treatment [because] continuous therapy is important for myeloma.” said the trial’s lead investigator, Sundar Jagannath,

Safety Profile

The safety profile of CARVYKTI® was consistent with previous analyses. In the safety assessment involving 208 patients in each arm:

• Adverse Events: 97% of patients experienced grade 3/4 treatment-emergent adverse events (TEAEs), with cytopenia being the most common.
• Infections: Treatment-emergent infections occurred in 64% of the CARVYKTI® arm compared to 76% in the standard therapies arm.

Since its launch, CARVYKTI® has been introduced in five countries globally, with over 3,500 patients treated to date. This innovative cell therapy represents a significant advancement in the management of multiple myeloma, offering new hope for patients who have limited treatment options.

The approval of CARVYKTI® marks a pivotal moment in the field of oncology, as it provides a novel therapeutic approach that leverages the power of the immune system to combat cancer. The ongoing commitment to expanding access to this treatment underscores the potential for CARVYKTI® to improve patient outcomes and enhance survival rates in a challenging disease landscape.

Mechanism of Action

CARVYKTI® is a BCMA-directed, genetically modified autologous T-cell immunotherapy. The process involves reprogramming a patient’s own T-cells using a transgene that encodes a chimeric antigen receptor (CAR). This CAR directs the modified T-cells to target and eliminate cells that express B-cell maturation antigen (BCMA), which is predominantly found on malignant multiple myeloma B-lineage cells as well as late-stage B cells and plasma cells.

The CARVYKTI® CAR protein features two single domains specifically targeting BCMA, designed to enhance binding affinity against human BCMA. Upon binding to BCMA-expressing cells, the CAR activates T-cells, promoting their proliferation and leading to the destruction of targeted malignant cells.

Conclusion

The advancements represented by CARVYKTI® highlight significant progress in the treatment of multiple myeloma, offering new hope for patients with limited options. Its unique mechanism as a BCMA-targeted therapy sets it apart in the field of immunotherapy, demonstrating the potential for personalized medicine to improve outcomes in cancer treatment.

“The three-year follow-up data from the Phase 3 CARTITUDE-4 study show a statistically significant and clinically meaningful improvement in overall survival and quality-of-life measures with CARVYKTI versus standard therapies—meaningful results that have the potential to transform the multiple myeloma treatment landscape. This adds to the growing body of data reinforcing the promise of a single infusion of CARVYKTI, which, in addition to demonstrating a significant overall survival benefit, also offers patients the opportunity of a period free from multiple myeloma treatment as early as second line.” – said Binod Dhakal, M.D., M.S., Associate Professor of Medicine at the Medical College of Wisconsin

Jennifer Yohrling:

“I’m proud to share that my team’s work on CARVYKTI has been awarded a Johnson Medal, recognizing our work in developing the first-and-only BCMA-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

The Johnson Medal is Johnson & Johnson’s most prestigious company-wide honor for excellence in research and development – it’s an honor to see our work celebrated. Thanks to our team’s hard work, CARVYKTI is the first cell therapy in multiple myeloma to significantly improve overall survival versus standard of care for patients as early as second line.

Congratulations again to my fellow medal recipients and the full CARVYKTI development team – it has been a privilege to work alongside each of you to make a difference in patient’s lives.”

Shelina Ramnarine:

“Jennifer Yohrling was my 1st manager at JNJ. I started two weeks after I defended my PhD and this was my 1st corporate job.

The way you and Barbara Kolb cared for me, supported me, and empathized with me in one of the biggest transition times of my life is a testament to both of your leadership. Thank you both for being models of leadership to me.

Jennifer, it’s been an honor to have monthly 1:1s with you almost 8 years later. You’ve taught me so much over the years about what it means to nurture, support and truly steward talent.

I’m so proud of you and this incredible achievement for your intellectual and technical capabilities. I’m also extremely honored to have benefitted from your kindness, care, coaching, mentorship, sponsorship and leadership! Thank you for being a model for us all!!”

Penny Heaton:

“I’m thrilled to share that the Johnson Medal, our company’s most prestigious award for excellence in research and development, is once again shining a spotlight on my company ’s groundbreaking achievements in healthcare.

This award recognizes Johnson & Johnson employees in R&D who dedicate their time, energy, and expertise to advancing healthcare solutions with the potential to transform the world. Their remarkable contributions not only push the boundaries of science but also improve lives around the world.

Please join me in celebrating the outstanding recipients of this year’s Johnson Medals: Ravi Bhatia, Arnob Banerjee, Werner Carell, Scott Corbett, Frank Kirchhoff, Loreta Marquez, Claudia Mourran, Vincent Roy, Jordan Schecter, Thorsten Sieß, Jimpo Wang, Jean Xu, and Jennifer Yohrling, whose dedication and ingenuity are truly inspiring. Their achievements exemplify the spirit of innovation and excellence that drives our company forward.

Congratulations to this year’s Johnson Medal winners! Your work is transforming healthcare and making a difference every day.”

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