Here is what CURE® learned about the recent FDA approval of Tevimbra for patients with esophageal squamous cell carcinoma (esophageal cancer).
The recent approval of Tevimbra (tislelizumab) by the Food and Drug Administration (FDA) for patients with unresectable or metastatic esophageal squamous cell carcinoma offers “more options for patients,” an expert told CURE®.
“Now, we need to be able to ideally identify the patients who are going to respond to the optimal therapeutics that we have for them,” explained Dr. Syma Iqbal during an interview with CURE®, after she noted that the gastrointestinal cancer space has “made huge strides” in the recent years.
Iqbal is an associate professor in the division of oncology at the Keck School of Medicine/Norris Comprehensive Cancer Center and section chief of gastrointestinal oncology.
She added that this approval is important for this specific population of patients with esophageal squamous cell carcinoma. Of note, Tevimbra demonstrated better benefits than chemotherapy and was less toxic.
“The study that was done that led to this approval, allowed patients [who were randomized] to receive standard-of-care chemotherapy versus this antibody, checkpoint inhibitor,” Iqbal said. “This allowed patients to receive a drug that was active, more active than chemotherapy that we have been using, and also a drug that was less toxic than the chemotherapy that we’ve been using. So it adds to our [collection of medicines] in treating these patients with squamous cell carcinoma of the esophagus.”
Tevimbra is a monoclonal antibody that binds to the PD-1 target in the body. The drug may help kill cancer cells, according to BeiGene, the manufacturing company of Tevimbra.
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Unmet Needs that Remain
In terms of unmet needs, Iqbal noted that it’s important for doctors and researchers to identify all of the patients who can benefit from these newly approved drugs, such as Tevimbra.
“What’s most important in any treatment, is trying to identify those patients who are going to benefit from the treatment that we’re giving them,” she said. “We’ve taken some step forward in that direction. We’re starting to figure out who is going to potentially benefit from the various therapeutics that we have.
“Ideally, we would want to know with greater accuracy, or who are the patients who are actually going to respond to these drugs, so that we can give them the appropriate targeted therapy at the appropriate time. That’s one of the biggest unmet needs in many of these new drugs that are getting approved right now.”
Side Effects of Tevimbra
Iqbal explained that the side effects of Tevimbra were similar to other PD-1 inhibitors, which include a “broad spectrum of side effects.”
“Patients can experience fatigue, skin rash, joint pain and inflammation in the lungs,” she said. “We need to monitor [patients] organ function, liver function and kidney function. Having said that, in general, these drugs are fairly well-tolerated. Even though [there are] a broad spectrum of side effects, they tend to be usually well-tolerated and tend to be grade 1 or 2.”
Mitigating and managing side effects from Tevimbra are made possible through steroids, Iqbal explained, especially when they are not severe. For patients with esophageal squamous cell carcinoma, she said that the steroids can “block that immune response.”
“If patients start to experience significant side effects, [doctors] can intervene by using steroids to essentially block that immune response,” she said. “Or, we can escalate from there to try to suppress the immune system if there is this kind of over-activation. It almost looks like an autoimmune disorder, where you’re seeing joint pain, rash, diarrhea, inflammation of the liver and inflammation to the organs.”
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