Eli Lilly LLY announced that the FDA has expanded the label of its BTK inhibitor drug, Jaypirca (pirtobrutinib), in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) indications.
Jaypirca is now approved in the United States under the accelerated pathway to treat adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
The approval is based on data from a subset of patients in the phase I/II BRUIN study, which evaluated Jaypirca in patients with hematologic malignancies, including CLL/SLL and mantle cell lymphoma (MCL). Data from the study showed that patients treated with Jaypirca achieved an overall response rate of 72% at a median duration of response of 12.2 months.
Per Lilly, Jaypirca utilizes a novel binding mechanism and has the largest body of evidence of any targeted therapy in patients previously treated with an approved BTK inhibitor, namely AbbVie ABBV/J&J’s JNJ Imbruvica, AstraZeneca’s AZN Calquence or BeiGene’s Brukinsa.
Following this label expansion, Jaypirca is the first and the only non-covalent (reversible) BTK inhibitor to have been shown to extend the benefit of targeting the BTK pathway in patients previously treated with a covalent BTK inhibitor. The BRUIN study enrolled patients who were treated with AbbVie/J&J’s Imbruvica, AstraZeneca’s Calquence or BeiGene’s Brukinsa.
This January, Jaypirca received accelerated approval from the FDA to treat adult patients with relapsed or refractory (r/r) MCL after at least two lines of systemic therapy (including a BTK inhibitor). Data from the BRUIN study also supported this approval.
Shares of Eli Lilly have surged 59.6% year to date compared with the industry’s 4.8% growth.
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Eli Lilly is evaluating Jaypirca in two ongoing phase III studies – BRUIN CLL-321 and BRUIN MCL-321 – which will also serve as confirmatory studies to support full approval for the drug in CLL/SLL and MCL indications.
Management claims that though data from the BRUIN CLL-321 study is yet to be formally reviewed, the study has achieved its primary endpoint. In this study, Jaypirca was compared to investigator’s choice of either the combination of Gilead’s Zydelig and rituximab or the bendamustine-rituximab pairing. Per Lilly, this data was shared with the FDA last month.
The BRUIN MCL-321 is comparing Jaypirca to the investigator’s choice of treatment, namely AbbVie/J&J’s Imbruvica, AstraZeneca’s Calquence or BeiGene’s Brukinsa.
Apart from the above studies, Lilly is also evaluating Jaypirca in separate late-stage studies as monotherapy and in combination with rituximab and AbbVie/Roche’s Venclexta to treat r/r CLL.
Currently, the three covalent options – marketed by AbbVie/J&J, AstraZeneca and BeiGene – are competing for market share in the CLL/SLL space. In the last few quarters, sales of Imbruvica have been declining steadily amid rising competition from Brukinsa and Calquence, all of which are approved by the FDA to treat similar indications.
CLL and SLL are forms of slow-growing non-Hodgkin lymphoma that develop from white blood cells known as lymphocytes. Though both indications are essentially the same disease, the main difference lies in the location of the cancer cells. In the case of CLL, the cancer cells are present in the blood, while the cancer cells are found in the lymph nodes in SLL.
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Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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