Clinical studies of venetoclax
| Published studies . | ||||||||
|---|---|---|---|---|---|---|---|---|
| Phase . | Year published . | Patient population . | Combination . | Administration . | No. of patients . | No. of t(11;14) . | ORR in all patients, % . | ORR in t(11;14), % . |
| 1 | 201776 | Relapsed/refractory | Venetoclax | Intrapatient escalation to maximum 300, 600, 900, and 1200 mg cohorts, expansion of 1200 mg cohort; dexamethasone could be added at progression on venetoclax | 66 | 30 | 21 | 40 |
| 61% bortezomib and lenalidomide double refractory | ||||||||
| 1b | 201777 | Relapsed/refractory | Venetoclax, bortezomib and dexamethasone | Intrapatient escalation to maximum 100, 200, 300, 400, 500, 600, 800, 1000, and 1200 mg venetoclax cohorts, expansion of 800 mg cohort; in combination with bortezomib and dexamethasone | 66 | 9 | 67 | 78 |
| 39% bortezomib refractory | ||||||||
| 53% lenalidomide refractory | ||||||||
| Published studies . | ||||||||
|---|---|---|---|---|---|---|---|---|
| Phase . | Year published . | Patient population . | Combination . | Administration . | No. of patients . | No. of t(11;14) . | ORR in all patients, % . | ORR in t(11;14), % . |
| 1 | 201776 | Relapsed/refractory | Venetoclax | Intrapatient escalation to maximum 300, 600, 900, and 1200 mg cohorts, expansion of 1200 mg cohort; dexamethasone could be added at progression on venetoclax | 66 | 30 | 21 | 40 |
| 61% bortezomib and lenalidomide double refractory | ||||||||
| 1b | 201777 | Relapsed/refractory | Venetoclax, bortezomib and dexamethasone | Intrapatient escalation to maximum 100, 200, 300, 400, 500, 600, 800, 1000, and 1200 mg venetoclax cohorts, expansion of 800 mg cohort; in combination with bortezomib and dexamethasone | 66 | 9 | 67 | 78 |
| 39% bortezomib refractory | ||||||||
| 53% lenalidomide refractory | ||||||||
| Ongoing studies . | |||||
|---|---|---|---|---|---|
| Phase . | Location . | Patient population . | Combination/Administration . | NCT . | Estimated completion . |
| 1b | US, Australia, France | Relapsed after at least 1 prior line of therapy | Venetoclax, bortezomib, and dexamethasone | NCT01794507 | 2018 |
| 1/2 | US, Australia, Canada, Europe | Part 1: t(11;14) relapsed/refractory; part 2: relapsed/refractory | Dose escalation of venetoclax with fixed doses of daratumumab and dexamethasone (+ bortezomib for part 2) | NCT03314181 | 2023 |
| 1/2 | US and Europe | Relapsed after at least 1 prior line of therapy, t(11;14) | Venetoclax ± dexamethasone | NCT01794520 | 2021 |
| 1b/2 | Europe | Relapsed/refractory 3 to 5 prior lines of therapy | Arm A: cobimetinib; arm B: cobimetinib plus venetoclax; arm C: cobimetinib, venetoclax plus atezolizumab | NCT03312530 | 2020 |
| 2 | US | Relapsed/refractory 1 to 3 prior lines of therapy | Venetoclax, carfilzomib, and dexamethasone | NCT02899052 | 2020 |
| 2 | US, Europe | Relapsed after at least 1 prior line of therapy, cohorts for t(11;14) positive and negative | Venetoclax, pomalidomide, and dexamethasone | NCT03567616 | 2020 |
| 3 | Worldwide | Considered sensitive or naive to proteasome inhibitors and received 1 to 3 prior lines of therapy | Venetoclax/placebo + bortezomib and dexmathasone | NCT02755597 | 2020 |
| 3 | Worldwide | t(11;14) Relapsed/refractory | Venetoclax and dexamethasone vs pomalidomide and dexamethasone | NCT03539744 | 2022 |
| Ongoing studies . | |||||
|---|---|---|---|---|---|
| Phase . | Location . | Patient population . | Combination/Administration . | NCT . | Estimated completion . |
| 1b | US, Australia, France | Relapsed after at least 1 prior line of therapy | Venetoclax, bortezomib, and dexamethasone | NCT01794507 | 2018 |
| 1/2 | US, Australia, Canada, Europe | Part 1: t(11;14) relapsed/refractory; part 2: relapsed/refractory | Dose escalation of venetoclax with fixed doses of daratumumab and dexamethasone (+ bortezomib for part 2) | NCT03314181 | 2023 |
| 1/2 | US and Europe | Relapsed after at least 1 prior line of therapy, t(11;14) | Venetoclax ± dexamethasone | NCT01794520 | 2021 |
| 1b/2 | Europe | Relapsed/refractory 3 to 5 prior lines of therapy | Arm A: cobimetinib; arm B: cobimetinib plus venetoclax; arm C: cobimetinib, venetoclax plus atezolizumab | NCT03312530 | 2020 |
| 2 | US | Relapsed/refractory 1 to 3 prior lines of therapy | Venetoclax, carfilzomib, and dexamethasone | NCT02899052 | 2020 |
| 2 | US, Europe | Relapsed after at least 1 prior line of therapy, cohorts for t(11;14) positive and negative | Venetoclax, pomalidomide, and dexamethasone | NCT03567616 | 2020 |
| 3 | Worldwide | Considered sensitive or naive to proteasome inhibitors and received 1 to 3 prior lines of therapy | Venetoclax/placebo + bortezomib and dexmathasone | NCT02755597 | 2020 |
| 3 | Worldwide | t(11;14) Relapsed/refractory | Venetoclax and dexamethasone vs pomalidomide and dexamethasone | NCT03539744 | 2022 |
As per www.clinicaltrials.gov and PubMed searches for “myeloma” and “venetoclax”.
ORR, overall response rate.