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Multiple myeloma (MM) is characterized by the proliferation of malignant plasma cells.
In recent years, new drugs have progressed rapidly, and the average overall survival of MM patients has improved, but there is still no cure.
Almost all MM patients will eventually relapse.
In recent years, researchers have researched and developed many bispecific antibodies (BsAbs) for the treatment of MM.
The results of the Phase 1 study of the three bispecific antibodies were selected as an oral report at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
The editor now organizes the main contents as follows for the reference of readers.
Abstract Number: 8006 Title: Efficacy and safety of BCMA-CD3 bispecific antibody elranatamab in patients with relapsed/refractory MM (RRMM) Elranatamab is a humanized targeting B cell maturation antigen (BCMA) and CD3 Bispecific antibodies.
As of August 4, 2020, 30 RRMM patients received 80 (n=6), 130 (n=4), 215 (n=4), 360 (n=4), 600 (n=6) per week Or 1000 (n=6) μg/kg elranatamab treatment, the median line number of previous treatment is 8.
87% of patients have triple refractory disease, 97% of patients have previously received anti-CD38 therapy, and 23% of patients have previously received targeted BCMA antibody-conjugated drugs or chimeric antigen receptor (CAR) T cell therapy.
The most common adverse events (TEAE) that occurred during treatment included lymphopenia (n=24,80%; grade 3 accounted for 20%, grade 4 accounted for 60%), cytokine release syndrome (CRS; n=22,73 %; all ≤ grade 2), anemia (n=17, 57%; grade 3 accounted for 43%, grade 4 accounted for 3%), injection site reactions (n=16, 53%; all ≤ grade 2), thrombocytopenia ( n=16, 53%; grade 3 accounted for 23%, grade 4 accounted for 17%), neutropenia (n=12, 40%; grade 3 accounted for 17%, grade 4 accounted for 7%).
CRS and immune effector cell-related neurotoxicity syndrome (n=6, 20%) were both ≤ grade 2, and the median duration was 2 days and 1.
5 days, respectively.
No DLT was observed.
According to the standards of the International Myeloma Working Group (IMWG), the overall response rate (ORR) of patients with a dose of ≥215 µg/kg is 75% (n=15/20), including partial response (PR, n=6), very Good partial remission (VGPR, n=3), complete remission (CR, n=1), strict complete remission (sCR, n=5); the median time to remission was 22 days, and 4 cases had previously received targeted Three (75%) patients treated with BCMA achieved remission (VGPR, n=2; sCR, n=1).
The study showed that the safety of elranatamab is controllable.
Patients with subcutaneous injection doses ≥215µg/kg have an ORR of 75% and a CR/sCR rate of 30%.
These results prove the safety and effectiveness of elranatamab in RRMM patients, and support the use of elranatamab as a monotherapy or in combination with standard therapies/new therapies for further research in MM patients.
Abstract Number: 8007 Title: BCMA-CD3 bispecific antibody teclistamab in RRMM patients Phase 1 study results update Teclistamab is a BCMA-CD3 bispecific IgG4 antibody.
As of February 4, 2021, 156 patients with relapsed, refractory or intolerant to existing therapies were enrolled.
84 patients received intravenous injection of teclistamab (dose: 0.
3–19.
2 mg/kg [once every two weeks]; dose: 19.
2–720 mg/kg [once a week]), and 72 patients received subcutaneous injection of teclistamab (dose: 80.
0–3000 mg/ kg, once a week); when the dose is ≥38.
4mg/kg, the dose needs to be gradually increased.
Part 1 of the study determined that the recommended phase 2 dose (RP2D) of teclistamab was 1500 mg/kg subcutaneously per week, with increased doses of 60.
0 and 300 mg/kg.
No DLT was observed.
40 patients (median follow-up 4.
3 months [range: 1.
1-10.
4+]) received RP2D treatment, the median age of patients was 62.
5 years (range: 39-84), 65% were male, and the median number of previous treatments was 5 (Range: 2-11).
According to the IMWG standard, the ORR was 65%; 58% of patients achieved ≥VGPR, 30% of patients achieved ≥CR; the median time to first confirmation of remission was 1.
0 months (range: 0.
2-3.
1), median remission The duration has not been reached.
Among 26 remission patients, 23 (88%) survived a median follow-up of 5.
3 months (range: 1.
2-10.
4+) and continued to receive treatment.
As time went by, the remission deepened.
The most common AEs were CRS (70%; no grade 3/4 events) and neutropenia (60%; grade 3/4 40%); 1 patient (3%) had grade 1 neurotoxicity.
Compared with intravenous injection, the median time of occurrence of CRS after subcutaneous injection is later.
Among patients with evaluable efficacy (n=40), the study showed that teclistamab is well tolerated under RP2D (1500 mg/kg subcutaneously per week) and has a long-lasting and deep remission effect.
The results of this study support teclistamab Further research on single drug or in combination with other drugs. Abstract Number: 8008 Title: The first in vivo phase 1 study of GPRC5D-CD3 bispecific antibody tallquetamab in RRMM patients.
Update Talquetamab is a bispecific antibody targeting GPRC5D and CD3.
As of February 8, 2021, a total of 174 RRMM patients who are intolerant to standard therapies have received Talquetamab treatment, 102 patients received intravenous injection (dose: 0.
5-180 mg/kg), and 72 patients received subcutaneous injection (dose: 5.
0–800mg/kg).
The first part of the study determined that the RP2D of Talquetamab was 405 mg/kg subcutaneously injected every week, and the increased doses were 10.
0 mg/kg and 60.
0 mg/kg.
No DLT was observed.
28 patients received RP2D treatment, the median age of the patients was 61.
5 years (range: 46-80 years), and the median number of previous treatments was 5.
5 (range: 2-14).
The most common AEs treated with RP2D were CRS (79%; grade 3 accounted for 4%; median onset time: one day after subcutaneous injection), neutropenia (64%; grade 3/4 accounted for 54%), anemia ( 57%; grade 3/4 accounted for 29%) and dysgeusia (57%, both grade 1/2); 32% of patients had infection (grade 3/4 accounted for 4%), and 7% of patients had neurotoxicity ( No level 3/4).
Overall, 75% of patients administered with RP2D had skin-related adverse events (no grade 3/4), including nail problems in 18%.
Among the 24 patients who received RP2D treatment with evaluable remission, the ORR was 63%, of which 50% reached ≥VGPR; 9/17 (53%) three-drug refractory patients and 3/3 (100%) patients The five-drug refractory patients all alleviated.
The median time from the use of RP2D to the first confirmation of remission is 1 month (range: 0.
2-3.
8); as time goes by, remission is durable and deepened (for patients in remission under RP2D, the median follow-up time is 6.
2 months [range 2.
7-9.
7+]). The results of the study showed that when administered with RP2D (subcutaneous injection of 405 mg/kg per week), talentamab showed a higher clinical remission rate and was well tolerated in RRMM patients.
The good efficacy, safety and convenience of subcutaneous administration of Talquetamab contribute to the further exploration of its single drug and combination therapy with new drugs.
Reference sources: 1.
Nizar J.
Bahlis, Efficacy and safety of elranatamab (PF-06863135), a B-cell maturation antigen (BCMA)-CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MM).
2021 ASCO Annual Meeting.
Abstract 8006.
2.
Amrita Y.
Krishnan, Updated phase 1 results of teclistamab, a B-cell maturation antigen (BCMA)×CD3 bispecific antibody, in relapsed/refractory multiple myeloma (MM).
2021 ASCO Annual Meeting.
Abstract 8007.
3.
Jesus G.
Berdeja, Updated results of a phase 1, first-in-human study of talquetamab, a G protein-coupled receptor family C group 5 member D (GPRC5D) × CD3 bispecific antibody, in relapsed/refractory multiple myeloma (MM).
2021 ASCO Annual Meeting.
Abstract 8008.
Stamp "read the original text", we make progress together
In recent years, new drugs have progressed rapidly, and the average overall survival of MM patients has improved, but there is still no cure.
Almost all MM patients will eventually relapse.
In recent years, researchers have researched and developed many bispecific antibodies (BsAbs) for the treatment of MM.
The results of the Phase 1 study of the three bispecific antibodies were selected as an oral report at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
The editor now organizes the main contents as follows for the reference of readers.
Abstract Number: 8006 Title: Efficacy and safety of BCMA-CD3 bispecific antibody elranatamab in patients with relapsed/refractory MM (RRMM) Elranatamab is a humanized targeting B cell maturation antigen (BCMA) and CD3 Bispecific antibodies.
As of August 4, 2020, 30 RRMM patients received 80 (n=6), 130 (n=4), 215 (n=4), 360 (n=4), 600 (n=6) per week Or 1000 (n=6) μg/kg elranatamab treatment, the median line number of previous treatment is 8.
87% of patients have triple refractory disease, 97% of patients have previously received anti-CD38 therapy, and 23% of patients have previously received targeted BCMA antibody-conjugated drugs or chimeric antigen receptor (CAR) T cell therapy.
The most common adverse events (TEAE) that occurred during treatment included lymphopenia (n=24,80%; grade 3 accounted for 20%, grade 4 accounted for 60%), cytokine release syndrome (CRS; n=22,73 %; all ≤ grade 2), anemia (n=17, 57%; grade 3 accounted for 43%, grade 4 accounted for 3%), injection site reactions (n=16, 53%; all ≤ grade 2), thrombocytopenia ( n=16, 53%; grade 3 accounted for 23%, grade 4 accounted for 17%), neutropenia (n=12, 40%; grade 3 accounted for 17%, grade 4 accounted for 7%).
CRS and immune effector cell-related neurotoxicity syndrome (n=6, 20%) were both ≤ grade 2, and the median duration was 2 days and 1.
5 days, respectively.
No DLT was observed.
According to the standards of the International Myeloma Working Group (IMWG), the overall response rate (ORR) of patients with a dose of ≥215 µg/kg is 75% (n=15/20), including partial response (PR, n=6), very Good partial remission (VGPR, n=3), complete remission (CR, n=1), strict complete remission (sCR, n=5); the median time to remission was 22 days, and 4 cases had previously received targeted Three (75%) patients treated with BCMA achieved remission (VGPR, n=2; sCR, n=1).
The study showed that the safety of elranatamab is controllable.
Patients with subcutaneous injection doses ≥215µg/kg have an ORR of 75% and a CR/sCR rate of 30%.
These results prove the safety and effectiveness of elranatamab in RRMM patients, and support the use of elranatamab as a monotherapy or in combination with standard therapies/new therapies for further research in MM patients.
Abstract Number: 8007 Title: BCMA-CD3 bispecific antibody teclistamab in RRMM patients Phase 1 study results update Teclistamab is a BCMA-CD3 bispecific IgG4 antibody.
As of February 4, 2021, 156 patients with relapsed, refractory or intolerant to existing therapies were enrolled.
84 patients received intravenous injection of teclistamab (dose: 0.
3–19.
2 mg/kg [once every two weeks]; dose: 19.
2–720 mg/kg [once a week]), and 72 patients received subcutaneous injection of teclistamab (dose: 80.
0–3000 mg/ kg, once a week); when the dose is ≥38.
4mg/kg, the dose needs to be gradually increased.
Part 1 of the study determined that the recommended phase 2 dose (RP2D) of teclistamab was 1500 mg/kg subcutaneously per week, with increased doses of 60.
0 and 300 mg/kg.
No DLT was observed.
40 patients (median follow-up 4.
3 months [range: 1.
1-10.
4+]) received RP2D treatment, the median age of patients was 62.
5 years (range: 39-84), 65% were male, and the median number of previous treatments was 5 (Range: 2-11).
According to the IMWG standard, the ORR was 65%; 58% of patients achieved ≥VGPR, 30% of patients achieved ≥CR; the median time to first confirmation of remission was 1.
0 months (range: 0.
2-3.
1), median remission The duration has not been reached.
Among 26 remission patients, 23 (88%) survived a median follow-up of 5.
3 months (range: 1.
2-10.
4+) and continued to receive treatment.
As time went by, the remission deepened.
The most common AEs were CRS (70%; no grade 3/4 events) and neutropenia (60%; grade 3/4 40%); 1 patient (3%) had grade 1 neurotoxicity.
Compared with intravenous injection, the median time of occurrence of CRS after subcutaneous injection is later.
Among patients with evaluable efficacy (n=40), the study showed that teclistamab is well tolerated under RP2D (1500 mg/kg subcutaneously per week) and has a long-lasting and deep remission effect.
The results of this study support teclistamab Further research on single drug or in combination with other drugs. Abstract Number: 8008 Title: The first in vivo phase 1 study of GPRC5D-CD3 bispecific antibody tallquetamab in RRMM patients.
Update Talquetamab is a bispecific antibody targeting GPRC5D and CD3.
As of February 8, 2021, a total of 174 RRMM patients who are intolerant to standard therapies have received Talquetamab treatment, 102 patients received intravenous injection (dose: 0.
5-180 mg/kg), and 72 patients received subcutaneous injection (dose: 5.
0–800mg/kg).
The first part of the study determined that the RP2D of Talquetamab was 405 mg/kg subcutaneously injected every week, and the increased doses were 10.
0 mg/kg and 60.
0 mg/kg.
No DLT was observed.
28 patients received RP2D treatment, the median age of the patients was 61.
5 years (range: 46-80 years), and the median number of previous treatments was 5.
5 (range: 2-14).
The most common AEs treated with RP2D were CRS (79%; grade 3 accounted for 4%; median onset time: one day after subcutaneous injection), neutropenia (64%; grade 3/4 accounted for 54%), anemia ( 57%; grade 3/4 accounted for 29%) and dysgeusia (57%, both grade 1/2); 32% of patients had infection (grade 3/4 accounted for 4%), and 7% of patients had neurotoxicity ( No level 3/4).
Overall, 75% of patients administered with RP2D had skin-related adverse events (no grade 3/4), including nail problems in 18%.
Among the 24 patients who received RP2D treatment with evaluable remission, the ORR was 63%, of which 50% reached ≥VGPR; 9/17 (53%) three-drug refractory patients and 3/3 (100%) patients The five-drug refractory patients all alleviated.
The median time from the use of RP2D to the first confirmation of remission is 1 month (range: 0.
2-3.
8); as time goes by, remission is durable and deepened (for patients in remission under RP2D, the median follow-up time is 6.
2 months [range 2.
7-9.
7+]). The results of the study showed that when administered with RP2D (subcutaneous injection of 405 mg/kg per week), talentamab showed a higher clinical remission rate and was well tolerated in RRMM patients.
The good efficacy, safety and convenience of subcutaneous administration of Talquetamab contribute to the further exploration of its single drug and combination therapy with new drugs.
Reference sources: 1.
Nizar J.
Bahlis, Efficacy and safety of elranatamab (PF-06863135), a B-cell maturation antigen (BCMA)-CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MM).
2021 ASCO Annual Meeting.
Abstract 8006.
2.
Amrita Y.
Krishnan, Updated phase 1 results of teclistamab, a B-cell maturation antigen (BCMA)×CD3 bispecific antibody, in relapsed/refractory multiple myeloma (MM).
2021 ASCO Annual Meeting.
Abstract 8007.
3.
Jesus G.
Berdeja, Updated results of a phase 1, first-in-human study of talquetamab, a G protein-coupled receptor family C group 5 member D (GPRC5D) × CD3 bispecific antibody, in relapsed/refractory multiple myeloma (MM).
2021 ASCO Annual Meeting.
Abstract 8008.
Stamp "read the original text", we make progress together
