Did CAR-T’s moment pass?

Leveraging our understanding of shifts in treatment class by disease, especially for Multiple Myeloma (MM) and Diffuse Large B Cell Lymphoma (DLBCL), as new brands in both classes emerge, the perspectives provided below offer insights on growth and answers to questions on competitiveness, perceptions, and opportunities to serve providers and patients alike.

Are Bispecific Therapies Outpacing CAR-T Referrals in Growth?

According to our data analysis, new entrants in both Bispecifics and CAR-T treatments in the Medicare
population classes face data gaps hindering HCP and Health System engagement. While CAR-T remains a key treatment, it faces perceived challenges from supply chain and care delivery perspectives. Upon launch, CAR-T manufacturers struggled to meet the demands, yet now that supply lines are robust, physicians perceive high acuity complications as a block to outpatient utilization. Meanwhile, Bispecific therapies are emerging rapidly—are they growing faster than the CAR-T incumbent referral network?

Adoption and Growth of Bispecifics

The bispecific therapy market demonstrates a strong upward trajectory during the last 18 months. As Figure 1 shows, month-over-month patient counts grew for several brands. We believe that increasing
access and HCP breadth breadth are powering growth in this class. (Please note, the graph shows a decline in the last two data points. This is not a negative inflection and is due to having a 2-week lag on monthly claims, so not all hospital and outpatient claims are adjudicated.)

Since April 2023, treated patient counts for Bispecific therapies reveal the following trends:

• Johnson & Johnson’s RYBREVANT led the eight other Brands in the spring of 2023 before J&J’sTECVAYLI saw significant growth, surpassing Genentech’s HEMLIBRA within months.
• Two brands — Amgen’s BLINCYTO, which initially rose above Genentech’s HEMLIBRA in April 2023, flattened out and both brands charted similar paths through October 2024
• Genmab’s EPKINLY and Genentech’s COLUMVI, which entered the market in spring and summer of 2023, respectively, showed measured growth until J&J’s TALVEY launched and spiked in September 2023.
• Within six months, Genmab’s EPKINLY surpassed three other brands, nearly catching up to J&J’s TALVEY before it saw its growth level off in the summer of 2024.
• While Pfizer’s ELREXFIO was the last to enter the bispecifics market in September 2023, it saw its sales climb steadily through September 2024, surpassing four previous launches.

Overall, Bispecific therapies exhibit a strong upward trend in patients on treatment and prescribing
providers counts, indicating and increasing and broad market penetration through better access.

Overcoming Challenges of CAR-T Cell Therapies

Over the past 18 months, as seen in Figure 2, claims volume for CAR-T therapy has been declining, following a typical S-curve trajectory for a maturing technology. As the prevalence of Diffuse Large B Cell Lymphoma (DLBCL), Multiple Myeloma (MM) and Acute Lymphoblastic Leukemia (ALL) has not decreased, and fulfillment ability builds, manufacturers have an opportunity to retap the value of CAR-T treatments.

In the early days of CAR-T, patients required multiple hand-off referrals before finding their way to an Academic Medical Center (AMC) for treatment. With the new access investments coming, CAR-T treatments are more available in ambulatory, non-institutional settings. In order to “stack the S-curve”, the industry should focus on the network-effect of HCP. By leveraging existing community hematology referral topography, a major adoption shift can unlock the value of the increased production capacity of CAR-T.

Examining the patient claim counts of CAR-T therapies since April 2023 in Figure 2 reveals notable trends among key brands.

• Novartis’ KYMRIAH launched and then dropped within a month and remained flat through fall 2024.
• Kite Pharma’s TECARTUS saw a measured growth through October 2023, second only to KYMRIAH and then tag teamed BMS‘s ABECMA through fall 2024.
• While BMS’s ABECMA saw an early spike in April 2023, patient counts then dropped and bottomed out in December 2023. Fortunately, the brand saw a spike in counts again in January 2024 and saw measured growth through the fall of 2024.
• J&J’s CARVYKTI experienced smaller fluctuations, continued to climb in patient counts leading the treatment adoption curve through the fall 2024.
• BMS BREYANZI remains among the top through the summer 2024, after adding CLL/SLL indications.
• Kite Pharma’s YESCARTA remained among the top two Brands until February 2024 and then followed a typical S-curve through October 2024.

To counteract this trend and adapt to heightened competition, we recommend two actions: using longitudinal data sources to visualize the referral networks, then update key physicians about improved access to CAR-T technology.

Analyzing Adoption and Market Dynamics of CAR-T and Bispecific Therapies for DLBCL

CAR-T therapies displayed a more variable trend than Bispecifics, and this trend is further supported by patient-count-based evaluation of treatments, across classes. The trends for four treatments, all indicated for DLBCL, two of which are CAR-T and two of which are Bispecifics, are shown in Figure 3.

Dig into our data, and uncover some trends in the treatment landscape. Here’s what we found:

• Genentech’s COLUMVI and Genmab’s EPKINLY, both Bispecific brands, are leading growth within therapeutic area of DLBCL.
• CAR-T Brands, Novartis’ KYMRIAH and Kite Pharma’s YESCARTA, on the other hand, are showing a decline in our analysis, as previously stated.

CareSet’s deeper commercial exploration includes insights into HCP and HCO counts over time, revealing
additional perspectives not visualized here. For example, Genentech’s COLUMVI is utilized in 3x more
institutions than Kite’s KYMRIAH, illustrating significant differences in access and resulting utilization rates.

Analyzing Multiple Myeloma Shifts from CAR-T to Bispecifics in Trends

In Multiple Myeloma, Figure 4 shows a similar trend. Note that the patient counts combine new patient starts and continuing patients. Bispecifics duration can range from several months to years and patients typically stay on the medication as long as it is effective and the side effects are manageable. However, as our deeper commercial data analysis shows, for an example, we found that some hematologists at Texas and Tennessee Oncology have stopped or substantially reduced using CAR-T for the MM/DLBCL patients all indicating a deeper preference ‘switched’ to Bispecific antibodies utilization.

• J&J’s TECVAYLI saw growth in Spring 2023 and remained the category lead in the Bispecific space, including TALVEY and Pfizer’s ELREXFIO, as well as CAR-T Brands, BMS’ ABECMA and J&J’s CARVYTI.
• Pfizer’s ELREXFIO saw measured growth from October 2023 to October 2024 in the bispecific space.
• BMS ABECMA saw an initial spike in Spring 2023 before dropping precipitously and falling below Johnson & Johnson’s CARVYKTI by early Summer. While it remained steady for a bit, it dropped below reportable Medicare patient threshold levels before climbing back up in January 2024 and sustaining measured growth through September 2024.
• Johnson & Johnson’s CARVYKTI saw steady growth initially from April 2023 through August 2024 and following an s-curve through September 2024.

Trends are signals that evolve over time. While the industry continues to adapt to perspective shifts surrounding CAR-T technology, the consensus is these trends can change. For now, as Figure 5 and our data indicate, a migration is underway.

We welcome the opportunity to meet and provide a detailed review of our findings—going beyond what is included in this free report—whether you’re seeking insights into Line-of-Therapy trends at leading institutions or visibility into referral networks of AMC-community physicians. Please contact us at ashish.patel@wordpress-1654971-6618904.cloudwaysapps.com or the contact form at www.wordpress-1654971-6618904.cloudwaysapps.com