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“The early data in each of these patient populations are promising, with confirmed partial responses observed in all four cancer types. Adverse events reported in each group were consistent with the overall safety profile observed in the trial and were generally of low severity, manageable, and reversible,” commented
“We are pleased to provide early data on patients with four different cancer types enrolled in our global Phase 1 study of BGB-A317. The preliminary safety profile and antitumor activity support continued development of BGB-A317. BGB-A317 is in registrational trials in
The multi-center, open-label Phase 1A/1B trial of BGB-A317 as monotherapy in advanced solid tumors is being conducted in
Preliminary Results in GC and EC (Abstract #387P)
The data presented at ESMO were from 83 patients with advanced or metastatic GC (46 patients) or EC (37 patients) treated with BGB-A317 at 2 mg/kg or 5 mg/kg Q2W or Q3W. At the time of the data cutoff, median treatment duration was 45 days (range 4–457 days) for patients with GC and 50 days (range 1–246 days) for patients with EC.
Adverse events (AEs) assessed by the investigator to be related to treatment occurred in 15 patients with GC (33%). Of those, abdominal pain (9%), decreased appetite (9%), fatigue (7%), nausea (7%), and pruritus (4%) were reported in more than one patient, and all of these cases were grades 1 or 2. AEs assessed to be related to treatment occurred in 15 patients with EC (41%). Of those, fatigue (16%), nausea (8%), decreased appetite (5%), infusion-related reaction (5%), and myalgia (5%) occurred in more than one patient, and all of these cases were grades 1 or 2. Only one patient in each cohort reported a treatment-related AE of grade 3 or higher: grade 3 proteinuria in one patient with GC and grade 3 dermatitis in one patient with EC. Serious AEs (SAEs) considered related to treatment included one case of diarrhea and one case of pyrexia, each occurring in patients with GC. Eight patients (two with GC, six with EC) had a treatment-emergent AE with a fatal outcome, none were assessed as related to treatment.
At the time of the data cutoff, the efficacy-evaluable population (measurable disease at baseline and at least one post-baseline tumor assessment, or progression or death) included 34 GC patients and 31 EC patients. Among GC patients, four achieved a confirmed partial response (PR) and three achieved stable disease (SD) per RECIST 1.1 criteria. Among EC patients, two achieved a confirmed PR and nine achieved SD. Three of the nine patients with EC who achieved SD also achieved an unconfirmed PR, including one who awaits response confirmation. At the time of the data cutoff, 27 patients remained on treatment.
Preliminary Results in HNSCC (Abstract #388P)
The data presented at ESMO were from 18 patients with advanced HNSCC treated with BGB-A317 at 5 mg/kg Q3W. At the time of the data cutoff, median treatment duration was 104 days (range 30–339 days).
AEs assessed by the investigator to be related to treatment occurred in seven patients with HNSCC (39%). Of those, only fatigue (11%, all grade 1 or 2) was reported in more than one patient. One case of grade 3 nausea was the only treatment-related AE of grade 3 or higher in severity. No patient discontinued treatment due to a treatment-related AE, and of the nine deaths reported, none were considered to be associated with the treatment.
Of the 17 efficacy-evaluable HNSCC patients, three achieved a confirmed PR and six achieved SD. At the time of the data cutoff, three patients remained on treatment.
Preliminary Results in OC (Abstract #389P)
The data presented at ESMO were from 51 patients with advanced or metastatic OC treated with BGB-A317 at different dose levels (0.5 to 10 mg/kg Q2W in dose escalation, 2 or 5 mg/kg Q2W or Q3W or 200 mg Q3W in dose expansion, or 5 mg/kg Q3W in indication expansion). At the time of the data cutoff, median treatment duration was 71 days (range 29–540 days).
AEs assessed by the investigator to be related to treatment occurred in 28 patients (55%). Of those, fatigue (18%), pruritus (10%), rash (10%), diarrhea (10%), lethargy (6%), nausea (6%), abdominal pain (4%), dry eye (4%), dry skin (4%), onychoclasis (4%), and maculo-papular rash (4%) were reported in more than one patient, and all, except one case of grade 3 diarrhea, were grades 1 or 2. Two additional treatment-related AEs of grade 3 or higher included one case each of grade 3 pyrexia and stomatitis. SAEs considered related to treatment occurred in three patients and included one case each of pyrexia, colitis, and mucosal inflammation.
Of the 50 efficacy-evaluable OC patients, two achieved a confirmed PR and 20 achieved SD. At the time of the data cutoff, six patients remained on treatment.
BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the encouraging clinical data of BGB-A317 and our and Celgene’s future development plans for BGB-A317. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including
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