Today, we’re thrilled to sit down with Ivan Kairatov, a renowned biopharma expert with extensive experience in research and development, particularly in the realm of oncology and innovative technologies. With a deep understanding of the industry’s evolving landscape, Ivan offers unique insights into the latest advancements in blood cancer treatments. In this conversation, we explore the promising developments surrounding an experimental drug for multiple myeloma, delving into its scientific significance, clinical trial outcomes, and potential impact on patients and the market. We also discuss the challenges of regulatory approval and the future of protein-degrading therapies in transforming cancer care.
Can you start by giving us an overview of what iberdomide is and why it holds such importance in the field of multiple myeloma treatment?
Absolutely. Iberdomide is an experimental drug being developed by Bristol Myers Squibb as a next-generation treatment for multiple myeloma, a type of blood cancer. It belongs to a class of protein-degrading medicines, which work by marking specific proteins critical for cancer cell survival for destruction by the body’s natural mechanisms. Its importance lies in its potential to succeed blockbuster drugs like Revlimid and Pomalyst, which have been cornerstones in treating this disease but are now facing declining sales or patent cliffs. Iberdomide represents a fresh approach, aiming to address unmet needs for patients whose cancer has returned or resisted initial treatments.
What sets iberdomide apart from other drugs currently used to treat multiple myeloma?
What makes iberdomide stand out is its enhanced protein-degrading mechanism. Unlike older drugs like Revlimid, which also target proteins but with less precision or potency over time due to resistance, iberdomide is designed to be more effective in breaking down those key proteins that myeloma cells rely on. This could potentially lead to deeper and more sustained responses in patients, especially those who’ve exhausted other options. It’s a step forward in tackling the adaptability of cancer cells.
Recent Phase 3 trial results showed promising outcomes for iberdomide when combined with other therapies. Can you walk us through the key findings from this study?
Certainly. The trial, known as Excaliber-RRMM, tested iberdomide in combination with Darzalex and dexamethasone against a standard regimen that included Darzalex, dexamethasone, and Velcade. The interim analysis revealed that the iberdomide combination significantly outperformed the standard in achieving minimal residual disease negativity. That means a much lower number of detectable cancer cells in the bone marrow post-treatment, which is a strong indicator of a deeper response to therapy. While specific numbers weren’t disclosed, hitting this primary endpoint is a big win at this stage.
Why is achieving minimal residual disease negativity such a critical measure for patients with multiple myeloma?
Minimal residual disease negativity, or MRD negativity, is a crucial benchmark because it reflects how thoroughly a treatment can eliminate cancer cells at a microscopic level. For multiple myeloma patients, achieving this status often correlates with longer periods of remission and better overall outcomes. It’s a sign that the disease burden is extremely low, reducing the likelihood of relapse in the near term. For patients, this can translate to improved quality of life and hope for more durable control of their condition.
Since the trial is still ongoing, can you explain what other aspects researchers are focusing on in this study?
Yes, the study isn’t finished yet. Beyond MRD negativity, researchers are closely monitoring progression-free survival, which is a co-primary endpoint. This measures how long patients go without their disease worsening. Additionally, they’re looking at overall survival as a key secondary goal, which assesses whether the treatment extends patients’ lives. These metrics are essential to fully understanding iberdomide’s impact and whether it can offer meaningful long-term benefits over existing therapies.
How important is progression-free survival in determining the success of a drug like iberdomide?
Progression-free survival is incredibly important because it directly addresses a core concern for patients and clinicians—how long can the treatment keep the cancer at bay? For a drug like iberdomide to be considered successful, especially in a regulatory context, it needs to show that it delays disease progression compared to standard treatments. This endpoint often serves as a stepping stone to proving broader benefits, like improved survival, and it’s a key factor in shaping treatment guidelines and payer decisions.
Bristol Myers has indicated plans to submit these trial results to health regulators. What can you tell us about the current status and potential challenges in this process?
From what’s been shared, Bristol Myers is preparing to submit the interim data to health regulators, though an approval likely hinges on meeting additional endpoints like progression-free survival. The process is still in early stages, and exact timelines haven’t been detailed publicly. Challenges could include ensuring the data’s robustness across all endpoints, addressing any safety concerns that might emerge, and demonstrating a clear advantage over existing regimens. Regulatory bodies will want comprehensive evidence that iberdomide offers a significant benefit, especially given the competitive landscape in multiple myeloma treatments.
Can you break down in simple terms how a protein-degrading drug like iberdomide works to fight cancer?
Sure. Think of protein-degrading drugs like iberdomide as molecular cleanup crews. Cancer cells, like those in multiple myeloma, depend on certain proteins to grow and survive. Iberdomide tags these harmful proteins for destruction, essentially flagging them so the body’s natural waste disposal system can break them down and get rid of them. By removing these proteins, the drug disrupts the cancer cells’ ability to function, leading to their death. It’s a targeted way to attack the disease at a fundamental level.
Analysts have projected that iberdomide could reach annual sales of around $1.3 billion by 2035. What’s your take on these forecasts?
I think the $1.3 billion projection is a reasonable starting point, reflecting cautious optimism about iberdomide’s potential. If the drug continues to show strong results in ongoing endpoints like progression-free survival and overall survival, there’s definitely room for upside, as some analysts have suggested. Factors like expanding its use to earlier lines of treatment or demonstrating superior efficacy could drive higher sales. However, risks remain, such as regulatory setbacks or competition from other emerging therapies in the multiple myeloma space, which could impact those numbers.
Looking ahead, what is your forecast for the future of protein-degrading therapies in blood cancer treatment?
I’m very optimistic about the future of protein-degrading therapies. They represent a paradigm shift in how we approach blood cancers like multiple myeloma. As we refine these drugs to be more precise and potent, I believe they’ll play a central role in personalized medicine, offering tailored solutions for patients based on their specific disease profiles. Over the next decade, I expect we’ll see these therapies not only improve outcomes but also reduce side effects, potentially becoming standard care in combination with other treatments. The key will be balancing innovation with accessibility to ensure patients worldwide can benefit.
