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June 16, 2021

LoA Update: Amgen’s bemarituzumab approval likelihood in gastroesophageal junction and gastric cancers jumps after Phase II ASCO reveal

Amgen’s bemarituzumab had its Likelihood of Approval (LoA) jump by 9 points and 5 points in first-line (1L) gastroesophageal junction (GEJ) and gastric cancer, respectively, as of 10 June.

By Reynald Castañeda

Amgen’s bemarituzumab had its Likelihood of Approval (LoA) jump by 9 points and 5 points in first-line (1L) gastroesophageal junction (GEJ) and gastric cancer, respectively, as of 10 June. This change was on the back of positive Phase II data presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually during 4–8 June.

On 4 June, Amgen announced updated results from the Phase II FIGHT trial combining bemarituzumab with chemotherapy in patients with FGFR2b-positive, HER2-negative 1L GEJ or gastric cancers. At a median follow-up of 12.5-months in 155 patients, the bemarituzumab/chemotherapy combination was associated with a 19.2-month median overall survival (OS), versus 12.5 months with chemotherapy alone, the trial’s secondary endpoint. In 96 patients overexpressing FGFR2b, the median OS for the combination was 25.4 months, compared with 11.1 months with chemotherapy alone.

Amgen said it will continue to work with regulatory agencies on next steps, including Phase III development, as per a media release. Bemarituzumab works by inhibiting FGFR2b on the surface of cancer cells, preventing tumour growth.

Bemarituzumab previously had an LoA of 25%, which increased to 32% in GEJ. The drug now has a 20% LoA, up from 15%, in gastric cancer. LoA is identified via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm.

Amgen has a market cap of $139.48bn.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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