Date: 2017-12-10
Type of
information: Presentation of results at a congress
phase: 1b-2
Announcement: presentation of results at the 59th American Society of Hematology (ASH) Annual Meeting
Company: Roche (Switzerland)
Product: polatuzumab vedotin
Action
mechanism:
- antibody drug conjugate. Polatuzumab vedotin (Anti-CD79b, DCDS4501A, RG7596) is an antibody drug conjugate (ADC) composed of a monoclonal antibody directed against CD79b, link to the cytotoxic, microtubule-disrupting agent, monomethyl auristatin E (MMAE). Polatuzumab vedotin is designed to selectively bind to CD79b on hematologic cells. It is being developed by Roche utilising Seattle Genetics ADC technology.
Disease: people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for hematopoietic stem cell transplant.
Therapeutic
area: Cancer - Oncology
Country: Australia, Canada, Czechia, France, Germany, Hungary, Italy, Republic of Korea, Netherlands, Spain, Turkey, UK, USA
Trial
details:
- GO29365 is a global, Phase Ib/II randomized study evaluating the safety, tolerability and activity of polatuzumab vedotin in combination with Rituxan or Gazyva plus bendamustine in relapsed or refractory (R/R) follicular lymphoma or diffuse large B-cell lymphoma (DLBCL). The Phase II stage randomized 80 patients with heavily pre-treated R/R DLBCL to receive either bendamustine plus Rituxan (BR), or BR in combination with polatuzumab vedotin. Patients enrolled had received a median of two prior therapies (a range of 1-7 prior therapies in the polatuzumab vedotin arm and range of 1-5 prior therapies in the BR alone arm). The primary endpoint was complete response (CR) at the end of treatment, as measured by positron emission tomography (PET) and assessed by an independent review committee (IRC). Secondary endpoints included objective response (OR; CR and partial response, PR) by investigator assessment and best objective response at the end of treatment by investigator and IRC assessment. Exploratory endpoints included duration of response (DOR), progression-free survival (PFS), event-free survival (EFS) and overall survival (OS). (NCT02257567)
Latest
news:
- • On December 10, 2017, Roche announced results from the randomized Phase II GO29365 study that compared polatuzumab vedotin in combination with bendamustine plus Rituxan® (rituximab) (BR) against BR alone in people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for hematopoietic stem cell transplant. The study met its primary endpoint, demonstrating that the addition of polatuzumab vedotin to BR increased complete response (CR) rates from 15 percent to 40 percent (p=0.012) at the end of treatment, as measured by positron emission tomography (PET) and assessed by an independent review committee (IRC). No unexpected safety signals were observed with the addition of polatuzumab vedotin to BR.
The data have been presented in a poster session at the 59th American Society of Hematology (ASH) Annual Meeting by Laurie Sehn, M.D., British Columbia Cancer Agency/University of British Columbia.
- The results showed:
- Polatuzumab vedotin plus BR significantly improved CR rates from 15 percent with BR alone to 40 percent (p=0.012), as measured by PET and assessed by IRC. A CR means no cancer could be detected at that time.
- The benefit observed was consistent across secondary endpoints, including improvements in investigator-assessed best objective response (OR; CR and partial response, PR) and CR with polatuzumab vedotin plus BR (70.0 percent OR, 57.5 percent CR) compared to BR alone (32.5 percent OR, 20.0 percent CR).
- Exploratory endpoints also improved with the addition of polatuzumab vedotin to BR:
* Patients treated with polatuzumab vedotin plus BR lived longer than those receiving BR alone (median overall survival; 11.8 months vs. 4.7 months; HR=0.35; 95 percent CI 0.19-0.67; p=0.0008).
* The addition of polatuzumab vedotin also increased the time until disease worsening or death (median progression-free survival: 6.7 months vs. 2.0 months; HR=0.31; 95 percent CI 0.18-0.55; p<0.0001), and the time between first response to treatment and disease worsening (duration of response: 8.8 months vs. 3.7 months).
- - No unexpected safety signals were observed with the addition of polatuzumab vedotin to BR. The most common Grade 3-4 adverse events with polatuzumab vedotin plus BR compared to BR alone, respectively, were low white blood cell count (46.2 percent vs. 35.9 percent), low white blood cell count with fever (10.3 percent vs. 5.1 percent), low platelet count (33.3 percent vs. 20.5 percent), anemia (25.6 percent vs. 12.8 percent) and infections (17.9 percent vs. 17.9 percent).
- Based on results from this study, polatuzumab vedotin was recently granted Breakthrough Therapy Designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of people with relapsed or refractory DLBCL.
Is
general: Yes
