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Development of MEDI4736, an anti-programmed cell death ligand 1 (PD-L1) antibody, as monotherapy or in combination with other therapies in the treatment of non-small cell lung cancer (NSCLC)

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NCT01693562 evaluates safety and efficacy of MEDI4736 administered every 2 or 3 weeks... NCT02000947 evaluates safety and efficacy of MEDI4736 in combination with tremelimumab, a human IgG2 anti-CTLA-4 mAb, at 4-week intervals... NCT01693562: As of May 2014, NSCLC cohort included 155 patients (pts) (median age 65 years [33-85], PS 0/1/unknown [25%/73%/2%], median 3 [0-7] prior treatments)... Median follow-up: 6 weeks (range 0-67)... Treatment-related adverse events (TRAEs): 29% (Grade [Gr] ≥3: 3%); none led to treatment discontinuation... TRAEs ≥Gr 3 noted in 3 pts: Gr 3 - ↑AST/ALT & Gr 5 myasthenia (MG) (n = 1), Gr 3 diarrhea/colitis (n = 1), Gr 4 - ↑amylase (n = 1)... TRAEs led to discontinuation in two subjects: Gr 5 MG and Gr3 colitis... In 12 response-evaluable pts (Figure 1), tumor shrinkage at 8 weeks: 0/3 pts cohort 1a; 6/9 pts cohorts 2a and 3a/b; disease control: 7/12 pts... Dose-escalation ongoing; total of 6 dose-levels, including cohort 5a (MEDI4736/Treme: 15/10 mg/kg), has been cleared since cut-off... Additional monotherapy NSCLC studies: Phase II 'ATLANTIC' (NCT02087423), Phase III 'PACIFIC' following chemo-radiotherapy (NCT02125461), Combination: Phase I + gefitinib (NCT02088112), and Phase Ib + AZD9291 (NCT02143466)... Monotherapy and combination: Phase III 'ARCTIC' vs standard-of-care.

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Red: Cohort1a (MEDI4735/Treme: 3/1); Green: Cohort 2a (MEDI4736/Treme 10/1); Gold: Cohort 3a (MEDI4736/Treme 15/1); Blue: Cohort 3b (MEDI4736/Treme 10/3).
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Figure 1: Red: Cohort1a (MEDI4735/Treme: 3/1); Green: Cohort 2a (MEDI4736/Treme 10/1); Gold: Cohort 3a (MEDI4736/Treme 15/1); Blue: Cohort 3b (MEDI4736/Treme 10/3).

Mentions: NCT02000947: As of April, 2014, 12 pts treated at 4 dose-levels (PS 0-1, median 3 [2-5] prior treatments). No DLTs observed in any cohort during DLT observation period. Most frequent TRAEs: -↑amylase, abdominal pain, arthralgia, colitis, diarrhea, epigastric discomfort, fatigue and nausea. TRAEs ≥Gr 3 noted in 3 pts: Gr 3 - ↑AST/ALT & Gr 5 myasthenia (MG) (n = 1), Gr 3 diarrhea/colitis (n = 1), Gr 4 - ↑amylase (n = 1). TRAEs led to discontinuation in two subjects: Gr 5 MG and Gr3 colitis. In 12 response-evaluable pts (Figure 1), tumor shrinkage at 8 weeks: 0/3 pts cohort 1a; 6/9 pts cohorts 2a and 3a/b; disease control: 7/12 pts. Dose-escalation ongoing; total of 6 dose-levels, including cohort 5a (MEDI4736/Treme: 15/10 mg/kg), has been cleared since cut-off.


Development of MEDI4736, an anti-programmed cell death ligand 1 (PD-L1) antibody, as monotherapy or in combination with other therapies in the treatment of non-small cell lung cancer (NSCLC)
Red: Cohort1a (MEDI4735/Treme: 3/1); Green: Cohort 2a (MEDI4736/Treme 10/1); Gold: Cohort 3a (MEDI4736/Treme 15/1); Blue: Cohort 3b (MEDI4736/Treme 10/3).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4288573&req=5

Figure 1: Red: Cohort1a (MEDI4735/Treme: 3/1); Green: Cohort 2a (MEDI4736/Treme 10/1); Gold: Cohort 3a (MEDI4736/Treme 15/1); Blue: Cohort 3b (MEDI4736/Treme 10/3).
Mentions: NCT02000947: As of April, 2014, 12 pts treated at 4 dose-levels (PS 0-1, median 3 [2-5] prior treatments). No DLTs observed in any cohort during DLT observation period. Most frequent TRAEs: -↑amylase, abdominal pain, arthralgia, colitis, diarrhea, epigastric discomfort, fatigue and nausea. TRAEs ≥Gr 3 noted in 3 pts: Gr 3 - ↑AST/ALT & Gr 5 myasthenia (MG) (n = 1), Gr 3 diarrhea/colitis (n = 1), Gr 4 - ↑amylase (n = 1). TRAEs led to discontinuation in two subjects: Gr 5 MG and Gr3 colitis. In 12 response-evaluable pts (Figure 1), tumor shrinkage at 8 weeks: 0/3 pts cohort 1a; 6/9 pts cohorts 2a and 3a/b; disease control: 7/12 pts. Dose-escalation ongoing; total of 6 dose-levels, including cohort 5a (MEDI4736/Treme: 15/10 mg/kg), has been cleared since cut-off.

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Please rate it.

NCT01693562 evaluates safety and efficacy of MEDI4736 administered every 2 or 3 weeks... NCT02000947 evaluates safety and efficacy of MEDI4736 in combination with tremelimumab, a human IgG2 anti-CTLA-4 mAb, at 4-week intervals... NCT01693562: As of May 2014, NSCLC cohort included 155 patients (pts) (median age 65 years [33-85], PS 0/1/unknown [25%/73%/2%], median 3 [0-7] prior treatments)... Median follow-up: 6 weeks (range 0-67)... Treatment-related adverse events (TRAEs): 29% (Grade [Gr] ≥3: 3%); none led to treatment discontinuation... TRAEs ≥Gr 3 noted in 3 pts: Gr 3 - ↑AST/ALT & Gr 5 myasthenia (MG) (n = 1), Gr 3 diarrhea/colitis (n = 1), Gr 4 - ↑amylase (n = 1)... TRAEs led to discontinuation in two subjects: Gr 5 MG and Gr3 colitis... In 12 response-evaluable pts (Figure 1), tumor shrinkage at 8 weeks: 0/3 pts cohort 1a; 6/9 pts cohorts 2a and 3a/b; disease control: 7/12 pts... Dose-escalation ongoing; total of 6 dose-levels, including cohort 5a (MEDI4736/Treme: 15/10 mg/kg), has been cleared since cut-off... Additional monotherapy NSCLC studies: Phase II 'ATLANTIC' (NCT02087423), Phase III 'PACIFIC' following chemo-radiotherapy (NCT02125461), Combination: Phase I + gefitinib (NCT02088112), and Phase Ib + AZD9291 (NCT02143466)... Monotherapy and combination: Phase III 'ARCTIC' vs standard-of-care.

No MeSH data available.