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Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies.
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| Zeitschriftentitel: | Journal of Clinical Oncology |
|---|---|
| Personen und Körperschaften: | , , , , , , , , |
| In: | Journal of Clinical Oncology, 35, 2017, 15_suppl, S. 7518-7518 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
American Society of Clinical Oncology (ASCO)
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| Schlagwörter: |
| author_facet |
Fegan, Christopher Danilov, Alexey Valeryevich Hodson, Daniel Salles, Gilles A. Starodub, Alexander Mitra, Siddhartha Yang, Yingsi Walter, Harriet Morschhauser, Franck Fegan, Christopher Danilov, Alexey Valeryevich Hodson, Daniel Salles, Gilles A. Starodub, Alexander Mitra, Siddhartha Yang, Yingsi Walter, Harriet Morschhauser, Franck |
|---|---|
| author |
Fegan, Christopher Danilov, Alexey Valeryevich Hodson, Daniel Salles, Gilles A. Starodub, Alexander Mitra, Siddhartha Yang, Yingsi Walter, Harriet Morschhauser, Franck |
| spellingShingle |
Fegan, Christopher Danilov, Alexey Valeryevich Hodson, Daniel Salles, Gilles A. Starodub, Alexander Mitra, Siddhartha Yang, Yingsi Walter, Harriet Morschhauser, Franck Journal of Clinical Oncology Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. Cancer Research Oncology |
| author_sort |
fegan, christopher |
| spelling |
Fegan, Christopher Danilov, Alexey Valeryevich Hodson, Daniel Salles, Gilles A. Starodub, Alexander Mitra, Siddhartha Yang, Yingsi Walter, Harriet Morschhauser, Franck 0732-183X 1527-7755 American Society of Clinical Oncology (ASCO) Cancer Research Oncology http://dx.doi.org/10.1200/jco.2017.35.15_suppl.7518 <jats:p> 7518 </jats:p><jats:p> Background: GS-4059 (ONO-4059) selectively and irreversibly inhibits Bruton’s tyrosine kinase (BTK) and entospletinib selectively inhibits spleen tyrosine kinase (SYK). Methods: This ongoing phase 1b study is evaluating the safety and tolerability of GS-4059 combined with entospletinib in patients with previously treated CLL, FL, SLL, MCL, MZL, WM, or non-GCB DLBCL. The study design uses 3+3 dose escalation (Table) withexpansion cohorts at potential phase 2 doses. Results: With a median duration of treatment of 22 weeks (range 3-56), 26/32 enrolled patients continue on treatment. The median age was 70 (43–85) years and 59% were men. Patients had the following diseases: CLL (n = 9), non-GCB DLBCL (7), FL (6), WM (5), MCL (2), SLL (2), and MZL (1). The median number of prior therapies was 2 (1–5). Five patients discontinued all study treatment, 4 due to disease progression (DLBCL x 2, MCL, MZL) and one due to withdrawal of consent. There has been 1 death on study due to progressive disease. The maximum tolerated dose was not reached. 90% of patients treated reported a treatment-emergent AE (TEAE) of which 48% were grade ≥3. Grade ≥3 TEAEs that were present in more than 1 patient were neutropenia (4), anemia, thrombocytopenia, pneumonia and AST/ALT elevation (2 each). The TEAEs present in >10% of patients were fatigue (7), petechiae (5), asthenia, constipation, contusion, dyspepsia, neutropenia and rash (4 each). No patients discontinued treatment due to AEs and all 5 patients with interruption of treatment for an AE successfully re-initiated therapy. 17 patients were evaluable for best overall response with the results as follows: 11 with partial responses (2 each with CLL, DLBCL, FL, SLL, WM, 1 with MCL); 4 with stable disease; 2 with progressive disease. Conclusions: GS-4059 at up to 160 mg in combination with entospletinib up to 400 mg daily was safe and well tolerated, supporting the continued clinical evaluation of the combination for the treatment of B-cell malignancies. Clinical trial information: NCT02457598 Clinical trial information: NCT02457598. [Table: see text] </jats:p> Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. Journal of Clinical Oncology |
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| title |
Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_unstemmed |
Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_full |
Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_fullStr |
Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_full_unstemmed |
Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_short |
Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_sort |
preliminary results of a phase ib study of gs-4059 in combination with entospletinib in patients with b-cell malignancies. |
| topic |
Cancer Research Oncology |
| url |
http://dx.doi.org/10.1200/jco.2017.35.15_suppl.7518 |
| publishDate |
2017 |
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7518-7518 |
| description |
<jats:p> 7518 </jats:p><jats:p> Background: GS-4059 (ONO-4059) selectively and irreversibly inhibits Bruton’s tyrosine kinase (BTK) and entospletinib selectively inhibits spleen tyrosine kinase (SYK). Methods: This ongoing phase 1b study is evaluating the safety and tolerability of GS-4059 combined with entospletinib in patients with previously treated CLL, FL, SLL, MCL, MZL, WM, or non-GCB DLBCL. The study design uses 3+3 dose escalation (Table) withexpansion cohorts at potential phase 2 doses. Results: With a median duration of treatment of 22 weeks (range 3-56), 26/32 enrolled patients continue on treatment. The median age was 70 (43–85) years and 59% were men. Patients had the following diseases: CLL (n = 9), non-GCB DLBCL (7), FL (6), WM (5), MCL (2), SLL (2), and MZL (1). The median number of prior therapies was 2 (1–5). Five patients discontinued all study treatment, 4 due to disease progression (DLBCL x 2, MCL, MZL) and one due to withdrawal of consent. There has been 1 death on study due to progressive disease. The maximum tolerated dose was not reached. 90% of patients treated reported a treatment-emergent AE (TEAE) of which 48% were grade ≥3. Grade ≥3 TEAEs that were present in more than 1 patient were neutropenia (4), anemia, thrombocytopenia, pneumonia and AST/ALT elevation (2 each). The TEAEs present in >10% of patients were fatigue (7), petechiae (5), asthenia, constipation, contusion, dyspepsia, neutropenia and rash (4 each). No patients discontinued treatment due to AEs and all 5 patients with interruption of treatment for an AE successfully re-initiated therapy. 17 patients were evaluable for best overall response with the results as follows: 11 with partial responses (2 each with CLL, DLBCL, FL, SLL, WM, 1 with MCL); 4 with stable disease; 2 with progressive disease. Conclusions: GS-4059 at up to 160 mg in combination with entospletinib up to 400 mg daily was safe and well tolerated, supporting the continued clinical evaluation of the combination for the treatment of B-cell malignancies. Clinical trial information: NCT02457598 Clinical trial information: NCT02457598. [Table: see text] </jats:p> |
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| author | Fegan, Christopher, Danilov, Alexey Valeryevich, Hodson, Daniel, Salles, Gilles A., Starodub, Alexander, Mitra, Siddhartha, Yang, Yingsi, Walter, Harriet, Morschhauser, Franck |
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| description | <jats:p> 7518 </jats:p><jats:p> Background: GS-4059 (ONO-4059) selectively and irreversibly inhibits Bruton’s tyrosine kinase (BTK) and entospletinib selectively inhibits spleen tyrosine kinase (SYK). Methods: This ongoing phase 1b study is evaluating the safety and tolerability of GS-4059 combined with entospletinib in patients with previously treated CLL, FL, SLL, MCL, MZL, WM, or non-GCB DLBCL. The study design uses 3+3 dose escalation (Table) withexpansion cohorts at potential phase 2 doses. Results: With a median duration of treatment of 22 weeks (range 3-56), 26/32 enrolled patients continue on treatment. The median age was 70 (43–85) years and 59% were men. Patients had the following diseases: CLL (n = 9), non-GCB DLBCL (7), FL (6), WM (5), MCL (2), SLL (2), and MZL (1). The median number of prior therapies was 2 (1–5). Five patients discontinued all study treatment, 4 due to disease progression (DLBCL x 2, MCL, MZL) and one due to withdrawal of consent. There has been 1 death on study due to progressive disease. The maximum tolerated dose was not reached. 90% of patients treated reported a treatment-emergent AE (TEAE) of which 48% were grade ≥3. Grade ≥3 TEAEs that were present in more than 1 patient were neutropenia (4), anemia, thrombocytopenia, pneumonia and AST/ALT elevation (2 each). The TEAEs present in >10% of patients were fatigue (7), petechiae (5), asthenia, constipation, contusion, dyspepsia, neutropenia and rash (4 each). No patients discontinued treatment due to AEs and all 5 patients with interruption of treatment for an AE successfully re-initiated therapy. 17 patients were evaluable for best overall response with the results as follows: 11 with partial responses (2 each with CLL, DLBCL, FL, SLL, WM, 1 with MCL); 4 with stable disease; 2 with progressive disease. Conclusions: GS-4059 at up to 160 mg in combination with entospletinib up to 400 mg daily was safe and well tolerated, supporting the continued clinical evaluation of the combination for the treatment of B-cell malignancies. Clinical trial information: NCT02457598 Clinical trial information: NCT02457598. [Table: see text] </jats:p> |
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| spelling | Fegan, Christopher Danilov, Alexey Valeryevich Hodson, Daniel Salles, Gilles A. Starodub, Alexander Mitra, Siddhartha Yang, Yingsi Walter, Harriet Morschhauser, Franck 0732-183X 1527-7755 American Society of Clinical Oncology (ASCO) Cancer Research Oncology http://dx.doi.org/10.1200/jco.2017.35.15_suppl.7518 <jats:p> 7518 </jats:p><jats:p> Background: GS-4059 (ONO-4059) selectively and irreversibly inhibits Bruton’s tyrosine kinase (BTK) and entospletinib selectively inhibits spleen tyrosine kinase (SYK). Methods: This ongoing phase 1b study is evaluating the safety and tolerability of GS-4059 combined with entospletinib in patients with previously treated CLL, FL, SLL, MCL, MZL, WM, or non-GCB DLBCL. The study design uses 3+3 dose escalation (Table) withexpansion cohorts at potential phase 2 doses. Results: With a median duration of treatment of 22 weeks (range 3-56), 26/32 enrolled patients continue on treatment. The median age was 70 (43–85) years and 59% were men. Patients had the following diseases: CLL (n = 9), non-GCB DLBCL (7), FL (6), WM (5), MCL (2), SLL (2), and MZL (1). The median number of prior therapies was 2 (1–5). Five patients discontinued all study treatment, 4 due to disease progression (DLBCL x 2, MCL, MZL) and one due to withdrawal of consent. There has been 1 death on study due to progressive disease. The maximum tolerated dose was not reached. 90% of patients treated reported a treatment-emergent AE (TEAE) of which 48% were grade ≥3. Grade ≥3 TEAEs that were present in more than 1 patient were neutropenia (4), anemia, thrombocytopenia, pneumonia and AST/ALT elevation (2 each). The TEAEs present in >10% of patients were fatigue (7), petechiae (5), asthenia, constipation, contusion, dyspepsia, neutropenia and rash (4 each). No patients discontinued treatment due to AEs and all 5 patients with interruption of treatment for an AE successfully re-initiated therapy. 17 patients were evaluable for best overall response with the results as follows: 11 with partial responses (2 each with CLL, DLBCL, FL, SLL, WM, 1 with MCL); 4 with stable disease; 2 with progressive disease. Conclusions: GS-4059 at up to 160 mg in combination with entospletinib up to 400 mg daily was safe and well tolerated, supporting the continued clinical evaluation of the combination for the treatment of B-cell malignancies. Clinical trial information: NCT02457598 Clinical trial information: NCT02457598. [Table: see text] </jats:p> Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. Journal of Clinical Oncology |
| spellingShingle | Fegan, Christopher, Danilov, Alexey Valeryevich, Hodson, Daniel, Salles, Gilles A., Starodub, Alexander, Mitra, Siddhartha, Yang, Yingsi, Walter, Harriet, Morschhauser, Franck, Journal of Clinical Oncology, Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies., Cancer Research, Oncology |
| title | Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_full | Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_fullStr | Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_full_unstemmed | Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_short | Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| title_sort | preliminary results of a phase ib study of gs-4059 in combination with entospletinib in patients with b-cell malignancies. |
| title_unstemmed | Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies. |
| topic | Cancer Research, Oncology |
| url | http://dx.doi.org/10.1200/jco.2017.35.15_suppl.7518 |