Genmab — August 2019
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Fra seneste CC omkring AXL
: With overexpressed AXL in lung cancer that was already quite clear during the dose escalation. And we have expanded the expansion cohort by a very large number of patients, and we hope to present you the initial, I think, 26 or so patient's worth of data and then we will -- we hope to present definitely at a response-rate level. And I think it's a bit too early to look at durability, Matthew -
But you're also developing an assay to actually screen patients for AXL expression, potentially for the next clinical study, and I think that will all become quite clear at the data presentation at an upcoming medical conference, and we will flag that up to you in the coming weeks.
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Fra ASCO abstract: Results: 47 pts with NSCLC (n=8), melanoma (n=9), ovarian (n=22), cervical (n=3) and endometrial (n=5) cancer enrolled in ph1 (1Q3W n=32; 3Q4W n=15). Most pts were female (87%), White (94%) and aged <65 y (66%). MTD was 2.2 mg/kg in 1Q3W arm and 1.0 mg/kg in 3Q4W arm; RP2D was 2.2 mg/kg 1Q3W. EnaV median elimination half-life: 0.9–2.2 d across doses/schedules. In 47 enrolled pts, there were 6 DLTs (Table). Most common AEs (any G; ≥40% pts) were fatigue (64%), nausea (57%)
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, diarrhea (47%), vomiting (45%) and decreased appetite (43%). 3 pts (1Q3W arm) had partial response (1 NSCLC [2.2 mg/kg dose]; 2 ovarian [1.5 and 2.4 mg/kg dose levels]). Conclusions: The RP2D of single agent EnaV in pre-treated pts with solid tumors was 2.2 mg/kg 1Q3W. EnaV had encouraging preliminary anti-tumor activity and will be evaluated in 7 ph2a expansion cohorts to further assess safety, tolerability, PK, anti-tumor activity and Axl expression. Funding: Genmab A/S. Clinical trial infor
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Genmab Announces Approval of DARZALEX
(daratumumab) in Frontline Multiple Myeloma in Japan
Company AnnouncementDARZALEX
approved in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant in Japan
Genmab to receive USD 7 million milestone payment
Approval based on data from Phase III ALCYONE study
Copenhagen, Denmark; August 22, 2019 -
Tusinde tak Sukker og Mobbyduck.
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Ot tusinde tak lom.
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@EL regarding the Nature Letter: 3 patients with ALL
received intensive chemotherapy for a third or fourth early relapse, achieved remission but remained MRD+. At that point, all of them were treated with daratumumab at doses and schedules identical to the myeloma protocol and achieved MRD− remission after 3–4 doses of induction. All the patients are currently alive and in MRD− remission for 44, 43, and 5 weeks, respectively. -
In these three heavily pretreated ALL patients (Table 1), administration of daratumumab was not associated with any significant immediate side effects....This novel approach may bring new hope to patients with a devastating disease such as relapsed ALL
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Result //
In the EGFR WT/ALK- cohort, 26 patients (median age 65.5 years, range 38–74; 57.7% male) with ECOG PS of 0 (11.5%) or 1 (88.5%) have been enrolled. Most patients (23/26) were treated with a checkpoint inhibitor. At a median follow-up of 18 weeks (range: 2–54), the most common (≥20%; any grade) treatment-emergent adverse events (TEAEs) were fatigue, constipation, nausea, decreased appetite, decreased weight, diarrhea, and vomiting. Two patients had a TEAE leading to dose reduction. -
Grade ≥3 TEAEs occurred in 12 patients, with the most common being gastrointestinal disorders in eight patients (constipation [n=1]; colitis, diarrhea, nausea, vomiting [n=2 each]; abdominal distension [n=1]. The confirmed ORR is 19% (95% CI: 8.5%, 37.9%). The disease control rate (CR+PR+SD) is 50% (13/26). Nine of 12 (75%) evaluable fresh biopsies were positive for AXL tumor cell staining.
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Conclusion //
In this high unmet need patient population, with advanced EGFR WT and ALK- NSCLC who are pretreated with PD-1/PD-L1 inhibitors and platimum-based therapies, EnaV monotherapy demonstrated a manageable safety profile and encouraging preliminary clinical activity. This cohort has expanded to allow up to 60 patients to gain further knowledge of AXL as a potential biomarker for responsiveness to EnaV and to gather additional data on safety and efficacy.
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