![GlobeNewswire by notified](/data/images/00735/0c0cc138-c6e5-42e0-969f-2f525b826378-w_300_h_100.png)
Merus’ Petosemtamab in Combination with Pembrolizumab Interim Data Demonstrates Robust Response Rate and Favorable Safety Profile in 1L r/m HNSCC
67% response rate observed among 24 evaluable patients
Conference Call on Tuesday, May 28th at 8 a.m. ET
UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 28, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced interim clinical data as of a March 6, 2024 data cutoff from the ongoing phase 1/2 trial of the bispecific antibody petosemtamab in combination with pembrolizumab. These data will be presented by Dr. Jerome Fayette M.D. Ph.D., Centre Léon Bérard, Lyon, France at the 2024 American Society of Clinical Oncology® (ASCO®) Annual Meeting on Monday, June 3 at 8 a.m. CT.
“In this interim dataset, petosemtamab in combination with pembrolizumab has demonstrated clinically meaningful activity in first line head and neck cancer, with a 67% response rate overall, observed across tumor PD-L1 expression levels and HPV status and with encouraging safety," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “I’m excited to announce plans to initiate a phase 3 registration trial of petosemtamab in combination with pembrolizumab, regardless of HPV status, in first line, PD-L1 expressing, head and neck cancer, which we expect will start by year end 2024.”
“Despite recent advancements, head and neck squamous cell carcinoma remains a deadly disease with limited treatment options,” added Dr. Fayette. “Based on these data, I’m optimistic petosemtamab, in combination with pembrolizumab, has the potential to become a new standard of care for patients with previously untreated head and neck cancer.”
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid Tumors
Rapid oral presentation title: Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 study
Observations in the presentation include:
- As of a March 6, 2024 data cutoff date, 45 patients (pts) were treated
- 26 patients were enrolled as of the abstract cutoff date
- The efficacy population consisted of 24 patients who had the opportunity for 4 or more months follow up, with ≥2 treatment cycles and ≥1 post-baseline tumor assessment; or who discontinued early due to disease progression or death
- Two patients were not included: One patient withdrew consent prior to first tumor assessment and the other patient discontinued due to toxicity with less than 2 cycles of treatment
- Response rates overall (N=24): 67%, including 1 confirmed complete response, 12 confirmed partial responses (PRs) and 3 unconfirmed PRs (all of whom confirmed after the data cutoff) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment, including
- 3 of 4 patients with HPV associated cancer responded
- Responses observed across PD-L1 levels (CPS 1-19: 60% [6/10]; CPS ≥ 20: 71% [10/14])
- At the time of data cutoff, 32 patients of the 45 enrolled, remained on treatment, including 14 of 16 responders and 18 of the initial 26 patients enrolled
- Median follow up of 3.6 months for the 45 patients
- 26 patients were enrolled as of the abstract cutoff date
- In 45 patients the combination was well tolerated and no significant overlapping toxicities with pembrolizumab were observed
- Treatment-emergent adverse events (AEs) were reported in 45 pts
- Most were Grade (G) 1 or 2 in severity (no G4–5 were observed)
- Infusion-related reactions (composite term) were reported in 38% (all Gs) and 7% (G3) of pts, most occurred during the first infusion and resolved
Presentation Details:
Abstract #: 6014
Session Title: Head and Neck Cancer
Session Date and Time: June 3, 2024, 8:00-9:30 a.m. CT
As full presentations become available at the 2024 ASCO® Annual Meeting, they will contemporaneously be available on the Merus website.
Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on Tuesday, May 28, 2024 at 8:00 a.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.
Date & Time: May 28, 2024 at 8:00 a.m. ET
Webcast link:Available on our website
Dial-in: Toll Free: 1 (800) 715-9871/ International: 1 (646) 307-1963
Conference ID:4160163
About Merus N.V.
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus’ website, https://www.merus.nl and https://twitter.com/MerusNV.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the clinical development of our clinical candidates, including petosemtamab, future clinical trial results or interim data, clinical activity and safety profile, and development plans in the on-going trials and described in forthcoming presentation; our belief that in this interim dataset, petosemtamab in combination with pembrolizumab has demonstrated clinically meaningful activity in first line head and neck cancer with encouraging safety; our plans to initiate a phase 3 registration trial of petosemtamab in combination with pembrolizumab, regardless of HPV status, in first line, PD-L1 expressing, head and neck cancer, which we expect will start by year end 2024; and the potential for petosemtamab in combination with pembrolizumab to become a new standard of care in 1L head and neck cancer. These forward-looking statements are based on management’s current expectations. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics®, Triclonics® and multispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the market volatility; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-Q for the quarter ended March 31, 2024 filed with the Securities and Exchange Commission, or SEC, on May 8, 2024, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.
To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Iveco Group signs a 150 million euro term loan facility with Cassa Depositi e Prestiti to support investments in research, development and innovation11.6.2024 12:00:00 CEST | Press release
Turin, 11th June 2024. Iveco Group N.V. (EXM: IVG), a global automotive leader active in the Commercial & Specialty Vehicles, Powertrain and related Financial Services arenas, has successfully signed a term loan facility of 150 million euros with Cassa Depositi e Prestiti (CDP), for the creation of new projects in Italy dedicated to research, development and innovation. In detail, through the resources made available by CDP, Iveco Group will develop innovative technologies and architectures in the field of electric propulsion and further develop solutions for autonomous driving, digitalisation and vehicle connectivity aimed at increasing efficiency, safety, driving comfort and productivity. The financed investments, which will have a 5-year amortising profile, will be made by Iveco Group in Italy by the end of 2025. Iveco Group N.V. (EXM: IVG) is the home of unique people and brands that power your business and mission to advance a more sustainable society. The eight brands are each a
DSV, 1115 - SHARE BUYBACK IN DSV A/S11.6.2024 11:22:17 CEST | Press release
Company Announcement No. 1115 On 24 April 2024, we initiated a share buyback programme, as described in Company Announcement No. 1104. According to the programme, the company will in the period from 24 April 2024 until 23 July 2024 purchase own shares up to a maximum value of DKK 1,000 million, and no more than 1,700,000 shares, corresponding to 0.79% of the share capital at commencement of the programme. The programme has been implemented in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (“MAR”) (save for the rules on share buyback programmes set out in MAR article 5) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. Trading dayNumber of shares bought backAverage transaction priceAmount DKKAccumulated trading for days 1-25478,1001,023.01489,100,86026:3 June 20247,0001,050.597,354,13027:4 June 20245,0001,055.705,278,50028:6 June20243,0001,096.273,288,81029:7 June 20244,0001,106.174,424,68
Landsbankinn hf.: Offering of covered bonds11.6.2024 11:16:36 CEST | Press release
Landsbankinn will offer covered bonds for sale via auction held on Thursday 13 June at 15:00. An inflation-linked series, LBANK CBI 30, will be offered for sale. In connection with the auction, a covered bond exchange offering will take place, where holders of the inflation-linked series LBANK CBI 24 can sell the covered bonds in the series against covered bonds bought in the above-mentioned auction. The clean price of the bonds is predefined at 99,594. Expected settlement date is 20 June 2024. Covered bonds issued by Landsbankinn are rated A+ with stable outlook by S&P Global Ratings. Landsbankinn Capital Markets will manage the auction. For further information, please call +354 410 7330 or email verdbrefamidlun@landsbankinn.is.
Relay42 unlocks customer intelligence with a new insights and reporting module, powered by Amazon QuickSight11.6.2024 11:00:00 CEST | Press release
AMSTERDAM, June 11, 2024 (GLOBE NEWSWIRE) -- Relay42, a leading European Customer Data Platform (CDP), is leveraging Amazon QuickSight to power its new real-time customer intelligence, reporting, and dashboard module. Harnessing the breadth and quality of customer data, the new Insights module empowers marketing teams to dive deep into customer behaviors and gain invaluable insights into the performance of their marketing programs across all online, offline, paid, and owned marketing channels. Preview of the Relay42 Insights module, in pre-beta version Key capabilities of the Relay42 Insights module include: Deep insights into customer behaviors: With the Relay42 Insights module, marketers can ask unlimited questions about their data and gain a deeper understanding of how to serve their customers more effectively. Simplicity with AI-powered querying: Marketers can use artificial intelligence to query their data using natural language search, reducing the reliance on data scientists. Us
Metasphere Labs Announces X Spaces Event on the Topic of Green Bitcoin Mining and Sound Money for Sustainability11.6.2024 10:30:00 CEST | Press release
VANCOUVER, British Columbia, June 11, 2024 (GLOBE NEWSWIRE) -- Metasphere Labs Inc. (formerly Looking Glass Labs Ltd., "Metasphere Labs" or the "Company") (Cboe Canada: LABZ) (OTC: LABZF) (FRA: H1N) is thrilled to announce an engaging Twitter Spaces event on Green Bitcoin mining, energy markets, and sustainability on July 3, 2024 at 2 p.m. ET. Follow us on X at MetasphereLabs for updates and to join the event. What We'll Discuss Bitcoin Mining Basics: Understand the fundamentals of Bitcoin mining.Energy Market Dynamics: Explore how Bitcoin mining interacts with energy markets.Sustainable Innovations: Learn about our efforts to promote sustainability in Bitcoin mining.Sound Money: Discover how tamper-proof currency can enhance stability.Efficient Payment Rails: See how fast, neutral payment systems support humanitarian projects.Carbon Footprint: Compare Bitcoin's environmental impact with traditional banking. "We're excited to host this event and dive into the critical topics of Bitcoin