Merus NV

Recent biologics deals include Duality Biologics' exclusive option agreement with GSK for ADC candidate DB-1324, Keros Therapeutics' global license agreement with Takeda for elritercept, Merus' license agreement with Partner Therapeutics for NRG1+ cancer antibody Zeno, and Sanofi's opening of a modular vaccine and biopharmaceutical facility in Singapore.

Jazz Pharmaceuticals' ZIIHERA® approved for HER2-positive biliary tract cancer; Merus's BIZENGRI® approved for NRG1+ pancreatic adenocarcinoma and NSCLC; AstraZeneca's IMFINZI® approved for limited-stage small cell lung cancer and under Priority Review for muscle-invasive bladder cancer.

Bizengri (zenocutuzumab-zbco) is the first FDA-approved treatment for advanced pancreatic cancer and NSCLC with NRG1 gene fusion. It targets HER2 and HER3 receptors to block tumor growth signals. Approved under accelerated approval, its continued availability depends on further trials. Clinical data showed response rates of 40% for pancreatic cancer and 33% for NSCLC. Common side effects include diarrhea, muscle pain, and nausea. Bizengri is marketed in the U.S. by Partner Therapeutics under a partnership with Merus.

The oncology biosimilars market was valued at USD 6.50 billion in 2024 and is projected to reach USD 35.79 billion by 2034, with a CAGR of 18.6%. Factors driving growth include the rising prevalence of cancer, regulatory support, and the development of cost-effective biosimilars. Key trends include the loss of exclusivity of key oncology drugs and support from regulatory bodies. Biosimilars are increasingly used in oncology globally, with segments such as breast cancer and lung cancer dominating the market.

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Merus announces interim clinical data for petosemtamab in r/m HNSCC, showing potential efficacy and safety. The phase 1/2 trial data, presented at ESMO Asia Congress, indicate a confirmed overall response rate of 36% with manageable safety profile. Further clinical development includes phase 3 trials in 1L and 2/3L r/m HNSCC, and phase 2 trials in mCRC, with initial data updates planned for 2025.

AstraZeneca and Daiichi Sankyo's cancer drug dato-dxd showed tumor control for 6 months in EGFR-mutated lung cancer patients; Agenus plans 60% spending cut to focus on late-stage colorectal cancer immunotherapy; Amgen invests $1 billion to expand NC manufacturing; USPTO withdraws proposed rule on preventing 'patent thickets'; Bluebird bio to undergo reverse stock split; FDA grants accelerated approval to Merus' zenocutuzumab for NRG1-altered lung and pancreatic cancers.

FDA updates include draft guidance on accelerated drug approval, a Salmonella outbreak advisory, a report on non-device software health risks, declining youth tobacco use, a video on FDA reorganization, accelerated approval for cancer treatments, a device shortage update, and approval of a diaphragm activation system for ventilator patients.

Merus NV received accelerated U.S. FDA approval for Bizengri (zenocutuzumab), the first targeted therapy for NRG1-positive pancreatic adenocarcinoma and non-small-cell lung cancer patients with advanced unresectable or metastatic disease.