Research report gives insights into oncologists views on CAR-T, Biosimilars and new AML therapies

2017 was a landmark year for advancement in oncology care. Some of the notable FDA approvals included the first two CAR T-cell therapies; several targeted agents for acute myeloid leukemia; and the first two biosimilars approved for therapeutic care in cancer.

Because most cancer patients are seen in the community setting, community oncologists will play an instrumental role in patient referral and adoption of these new therapies. To better understand their perceptions about these treatment options and potential barriers to uptake, Cardinal Health Specialty Solutions surveyed more than 200 oncologists from across the United States and issued a report with the findings. Some of the key conclusions are summarized below.

CAR T-cell therapy
Chimeric antigen receptor T-cell therapy has emerged as the next important movement in immunotherapy innovation. Earlier this year, the FDA approved two CAR-T therapies:
• Novartis’ Kymriah, indicated for treatment of pediatric and young adult patients (up to 25 years old) with a form of acute lymphoblastic leukemia, and
• Kite Pharma’s Yescarta, indicated for adult patients with relapsed/refractory diffuse large B cell and high-grade lymphomas who have undergone two regimens of chemotherapy without success.

Our research with community oncologists demonstrated mixed views about the emergence of CAR T-cell therapies. While 51 percent see CAR-T as a potentially game-changing approach, there are barriers that could slow referrals. Concerns about costs (57 percent) and toxicity (41 percent) were both cited as factors that might limit referrals. The complexity and logistics of administering CAR-T treatment was also indicated as a top barrier to prescribing.

These statements suggest an opportunity for manufacturers to help oncologists better understand the CAR-T therapeutic process, the incidence of toxicity and how it will be managed, the potential for relapse, and follow-up needs once patients return to the community. It also indicates a potential need for patient support programs to help patients manage financial challenges.

Biosimilars
To date, eight biosimilars – biological medicines that contain a highly similar version of the active substance in an approved biologic product – have been approved by the FDA, including three for use in cancer patients. With a significant number of biosimilars in the late-stage pipeline, more approvals are expected in the next few years. As these products come to market, oncologists will be key in determining how quickly they are adopted.

Despite the fact that most oncologists lack first-hand experience prescribing biosimilars, the awareness of this emerging drug class is strong, with more than 84 percent of participating oncologists saying they are somewhat or very familiar. We also found that more than 44 percent are comfortable with the FDA approval process for biosimilars, although label expansion through extrapolation is a concern for 35 percent. In spite of this, the majority of oncologists say they are willing to prescribe biosimilars regardless of whether the product is supportive care or therapeutic, or whether it is a palliative treatment or used with curative intent. Cost savings appears to be a major motivating factor – 66 percent of oncologists say it is very or extremely important to saving costs when prescribing biosimilars.

Acute myeloid leukemia therapies
For decades, acute myeloid leukemia patients have had few treatment options. Those who were fit and able to tolerate chemotherapy were treated with modestly effective “7+3” chemotherapy regimen, while older and less fit patients were often referred for palliative care. However, this year three new targeted therapies for AML have been approved by the FDA – two targeting genetic mutations and one for AML patients who are CD33-positive.

While these advances offer new hope for many AML patients, they also require physicians to change how they evaluate and select treatment options. Genetic testing with timely and reproducible results is necessary to identify patients who can benefit from these targeted drugs. In our survey, we find that 85 percent of oncologists consistently test all AML patients for the presence of genomic targets or mutations. However, less than 50 percent have access to the test at their own institution, and 21 percent say the turnaround time for results exceeds 14 days. This suggests that while physicians are adopting the right behaviors, broad access and timely results of genetic testing may be an ongoing challenge.

The question of whether the new treatments will lead to improved access to AML care, particularly for elderly patients, is also important. Registry data shows that historically almost 20 percent of newly diagnosed AML patients received palliative care rather than active therapy1. While we do not have definitive insights into how these trends may change, our research shows that 31 percent of oncologists are more likely to refer newly diagnosed AML patients to academic centers now that new treatment options are available, suggesting that some patients who would have previously received palliative care may now have the opportunity to receive active therapy.

These research results indicate that while scientific advances are rapidly providing patients and providers with promising new treatment options for complex diseases, the swift adoption of these therapies is not guaranteed. Mitigating factors, including concerns from physicians about costs and toxicity, as well as availability of related services such as testing and patient support programs, must be addressed by manufacturers as these therapies are brought to market.

For more detailed insights, download the full report at www.cardinalhealth.com/oncologyinsights.

1 Medeiros B, Big data analysis of treatment patterns and outcomes among elderly acute myeloid leukemia patients in the United States, Ann Hematol. 2015; 94:1127–1138

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