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Nathan Fowler
Felipe Samaniego
ATLANTA – A single agent was administered with an effective PI3K-delta inhibitor and appeared to be well tolerated in patients with recurrent / refractory marginal zone lymphoma, based on data from the UNITY-2 phase 2 trial. NHL presented at the annual meeting of the American Association for Cancer Research.
"Umbralisib is an inhibitor of PI3 kinase, and the PI3 kinase signaling pathway is generally used in B-cell malignancies and other cancers. it is an important factor of cell proliferation ", Felipe Samaniego, MD, Associate Professor in the Department of Lymphoma / Myeloma, Division of Cancer Medicine at the MD Anderson Cancer Center of the University of Texas, said in an interview with HemOnc today. "This project is one of the components of a much larger research enterprise. We focus on marginal area lymphoma only because there is no approved treatment for this designation. "
In January, the FDA granted the revolutionary therapy status to paraplalis (TGR-1202, TG Therapeutics) for adults with lymphoma in marginal areas who had already undergone at least one anti-CD20 treatment.
For the Phase 2 clinical trial, Samaniego and colleagues recruited 69 patients with histologically confirmed marginal zone lymphoma. Eligible participants had an ECOG performance index of 2 or less and had received at least one prior treatment, including anti-CD20 treatment.
Participants received 800 mg of paraplalisib orally twice daily until intolerable progression or toxicity. The overall response rate, evaluated by an independent review committee, was the primary criterion for evaluation. The duration of the response and the PFS served as secondary endpoints.
Researchers reported a researcher-rated ORR in 38 patients (median age: 67 years, range: 34 to 81 years) with at least 6 months of follow-up (median: 9.6 months). Most patients (68%) had received at least one immunotherapy containing anti-CD-20 and seven had previously received prior rituximab monotherapy (Rituxan, Genentech, Biogen).
The results showed one ORR among the 38 patients by 55%, including four complete responses and 17 partial responses. In addition, 11 participants had stable disease, which resulted in a clinical benefit rate of 84%.
"We have seen that more than 50% of patients responded, and the most interesting is that it appears that the responses occurred regardless of the subtype of marginal zone lymphoma", lead author Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research at the Lymphoma / Myeloma Department of the MD Anderson Cancer Center of the University of Texas, a HemOnc today. "For example, with marginal splenic lymphoma, extranodal marginal zone lymphoma, and lymphoma of the nodal marginal area, we had responses close to 57%, which is impressive."
The initial response occurred at a median of 2.7 months, while the median duration of the response was not reached (95% CI, 8.4 – not achieved). Progression-free survival at 12 months was 71%.
The most common side effects were diarrhea (45%), nausea (29%), fatigue (26%), headache (26%), cough (24%) and loss of appetite. (21%). Neutropenia (8%), febrile neutropenia (5%) and diarrhea (5%) were the most common adverse events of grade 3 to 4. At the time of the data cut, 16 patients had discontinued treatment.
The researchers noted study boundaries, including the small patient population and short follow-up time.
According to Fowler, the relative lack of significant adverse events that occurred during prolonged exposure to paraplalisib is an important finding.
"With PI3K inhibitors in particular, we worry about things like colitis or pneumonitis with more exposure to a drug, and we did not seem to see that," he said. "In fact, if you look at the incidence of grade 3 diarrhea, only one patient had it for 6 months. that's all. This is really relevant because many of the FDA-approved drugs have already been injected into PI3K-delta, and we wonder: "Which of these drugs will become a drug used in the community?" Unfortunately, because diarrhea and other side effects, few people have used these drugs.
Fowler added that the study shows that trials on cancers such as marginal zone lymphoma are possible and valid.
"This test shows that we can take a rather rare subtype of non-Hodgkin lymphoma, we can recruit patients, we can see an activity with a single agent and we can potentially get approval from the FDA, "he said. "In the past, marginal lymphoma did not get much attention because many people thought it was too rare to have a subtype to study and we would not be able to recruit patients and get it. 'approval. This essay and a previous essay published about a year ago suggest that it is possible to go ahead in this space. "- by Jennifer Byrnote
Reference:
Fowler NH et al. Summary CT132. Presented at: AACR Annual Meeting; From March 29 to April 3, 2019; Atlanta.
Disclosures: TG Therapeutics funded the study. Fowler reports scientific advisory board roles to Bayer, Gilead Sciences, TG Therapeutics and Verastem Oncology and TG Therapeutics' research funding. Samaniego does not report any relevant financial information. Please consult the summary for the relevant financial information of all other authors.
Nathan Fowler
Felipe Samaniego
ATLANTA – A single agent was administered with an effective PI3K-delta inhibitor and appeared to be well tolerated in patients with recurrent / refractory marginal zone lymphoma, based on data from the UNITY-2 phase 2 trial. NHL presented at the annual meeting of the American Association for Cancer Research.
"Umbralisib is an inhibitor of PI3 kinase, and the PI3 kinase signaling pathway is generally used in B-cell malignancies and other cancers. it is an important factor of cell proliferation ", Felipe Samaniego, MD, Associate Professor in the Department of Lymphoma / Myeloma, Division of Cancer Medicine at the MD Anderson Cancer Center of the University of Texas, said in an interview with HemOnc today. "This project is one of the components of a much larger research enterprise. We focus on marginal area lymphoma only because there is no approved treatment for this designation. "
In January, the FDA granted the revolutionary therapy status to paraplalis (TGR-1202, TG Therapeutics) for adults with lymphoma in marginal areas who had already undergone at least one anti-CD20 treatment.
For the Phase 2 clinical trial, Samaniego and colleagues recruited 69 patients with histologically confirmed marginal zone lymphoma. Eligible participants had an ECOG performance index of 2 or less and had received at least one prior treatment, including anti-CD20 treatment.
Participants received 800 mg of paraplalisib orally twice daily until intolerable progression or toxicity. The overall response rate, evaluated by an independent review committee, was the primary criterion for evaluation. The duration of the response and the PFS served as secondary endpoints.
Researchers reported a researcher-rated ORR in 38 patients (median age: 67 years, range: 34 to 81 years) with at least 6 months of follow-up (median: 9.6 months). Most patients (68%) had received at least one immunotherapy containing anti-CD-20 and seven had previously received prior rituximab monotherapy (Rituxan, Genentech, Biogen).
The results showed one ORR among the 38 patients by 55%, including four complete responses and 17 partial responses. In addition, 11 participants had stable disease, which resulted in a clinical benefit rate of 84%.
"We have seen that more than 50% of patients responded, and the most interesting is that it appears that the responses occurred regardless of the subtype of marginal zone lymphoma", lead author Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research at the Lymphoma / Myeloma Department of the MD Anderson Cancer Center of the University of Texas, a HemOnc today. "For example, with marginal splenic lymphoma, extranodal marginal zone lymphoma, and lymphoma of the nodal marginal area, we had responses close to 57%, which is impressive."
The initial response occurred at a median of 2.7 months, while the median duration of the response was not reached (95% CI, 8.4 – not achieved). Progression-free survival at 12 months was 71%.
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The most common side effects were diarrhea (45%), nausea (29%), fatigue (26%), headache (26%), cough (24%) and loss of appetite. (21%). Neutropenia (8%), febrile neutropenia (5%) and diarrhea (5%) were the most common adverse events of grade 3 to 4. At the time of the data cut, 16 patients had discontinued treatment.
The researchers noted study boundaries, including the small patient population and short follow-up time.
According to Fowler, the relative lack of significant adverse events that occurred during prolonged exposure to paraplalisib is an important finding.
"With PI3K inhibitors in particular, we worry about things like colitis or pneumonitis with more exposure to a drug, and we did not seem to see that," he said. "In fact, if you look at the incidence of grade 3 diarrhea, only one patient had it for 6 months. that's all. This is really relevant because many of the FDA-approved drugs have already been injected into PI3K-delta, and we wonder: "Which of these drugs will become a drug used in the community?" Unfortunately, because diarrhea and other side effects, few people have used these drugs.
Fowler added that the study shows that trials on cancers such as marginal zone lymphoma are possible and valid.
"This test shows that we can take a rather rare subtype of non-Hodgkin lymphoma, we can recruit patients, we can see an activity with a single agent and we can potentially get approval from the FDA, "he said. "In the past, marginal lymphoma did not get much attention because many people thought it was too rare to have a subtype to study and we would not be able to recruit patients and get it. 'approval. This essay and a previous essay published about a year ago suggest that it is possible to go ahead in this space. "- by Jennifer Byrnote
Reference:
Fowler NH et al. Summary CT132. Presented at: AACR Annual Meeting; From March 29 to April 3, 2019; Atlanta.
Disclosures: TG Therapeutics funded the study. Fowler reports scientific advisory board roles to Bayer, Gilead Sciences, TG Therapeutics and Verastem Oncology and TG Therapeutics' research funding. Samaniego does not report any relevant financial information. Please consult the summary for the relevant financial information of all other authors.
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