At the upcoming annual meeting of annual meeting of the American Society of Clinical Oncology, held May 30 through June 3, 2025 in Chicago, Illinois., EMD Serono* will highlight new data from studies across more than 12 tumor types. Some of the studies and investigational agents involve the most challenging cancers.
The findings to be presented illustrate the company’s dedication to advancing innovative therapies for a wide range of diseases, from common cancers to rare non-malignant neoplasms, including:
- Data from Phase 3 MANEUVER study (NCT05804045) showing potentially best-in-class pimicotinib (ABSK021) significantly improves physical function and symptoms in patients diagnosed with tenosynovial giant cell tumor, to be featured in oral presentation on Sunday, June 1
- The latest results for potential first-in-class anti-CEACAM5 ADC precemtabart tocentecan (M9140; see ADC Drugmap), highlighting strong rationale for further development in colorectal cancer (CRC)
- New findings from RWE evidence and Phase 2 data from JAVELIN Bladder Medley further building on the benefit from avelumab (Bavencio®)** in the first-line maintenance setting in advanced bladder cancer.
“The new clinical data we are presenting showcase our dedication to advancing innovative therapies for a wide range of diseases—spanning from common cancers to rare non-malignant neoplasms,” noted Victoria Zazulina, M.D., Head of Development Unit, Oncology, for the Healthcare business of Merck KGaA,* Darmstadt, Germany.
“From encouraging early data for our lead antibody-drug conjugate, precemtabart tocentecan, in patients with advanced CRC, to new Phase 2 findings and real-world evidence that reinforce the value of avelumab first-line maintenance as a treatment option for advanced bladder cancer, to detailed Phase 3 results for pimicotinib in tenosynovial giant cell tumor, we are working to advance treatments that provide hope to patients and their families.”
MANEUVER data in the treatment of TGCT
Pimicotinib is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib has been granted breakthrough therapy designation (BTD) for the treatment of inoperable TGCT by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA).
Detailed results from Part 1 of the Phase 3 MANEUVER study of pimicotinib in the treatment of patients with TGCT, conducted by Abbisko Therapeutics will be presented for the first time during the Sarcoma Oral Abstract Session on June 1, at 9:57 a.m. CST.
In the trial, pimicotinib significantly improved objective response rate versus placebo, the primary endpoint, as well as all key secondary endpoints. Pimicotinib was well-tolerated. (Abstract 11500)
Precemtabart tocentecan
The clinical investigation of precemtabart tocentecan, an investigational antibody-drug conjugate (ADC) for the treatment of patients diagnosed with CRC. Precemtabart tocentecan targets (CarcinoEmbryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5), a cell surface protein with limited expression in adult healthyor normal, tissues, but with a high expression in various adenocarcinomas, including CRC. [1]
Precemtabart tocentecan is the first anti-CEACAM5 ADC with the topoisomerase 1 inhibitor payload exatecan, linking the anti-CESCAM5 antibody backbone via a ß-glucuronide linker to the payload. The drug, with drug-to-antibody ratio (DAT) = 8, is highly stable in circulation.
Beyond the direct effect on the target cell, precemtabart tocentecan has been shown in preclinical research to induce tumor cell death through a bystander effect permeating the cell membrane to neighboring cells, inducing apoptosis (cell death). This bystander effect within the tumor microenvironment may enhance efficacy, particularly in tumors with heterogenous CEACAM5 expression. Precemtabart tocentecan is currently being evaluated across tumor types with CEACAM5 expression and a high unmet need, including metastatic colorectal cancer (mCRC), gastric cancer (GC), non-small cell lung cancer (NSCLC), and pancreatic ductal adenocarcinoma (PDAC).
New findings from the Phase 1 PROCEADE-CRC 01 study (NCT05464030) include data from the dose-optimization part in 60 irinotecan-refractory metastatic CRC patients (3L+) demonstrating encouraging efficacy at doses of 2.4 mg/kg and 2.8 mg/kg every 3 weeks (Q3W) and a predictable and manageable safety profile. These data, which showed a higher ORR and similar safety at the 2.8 mg/kg dose, support the rationale for selecting this as the recommended dose for further development in CRC and other solid tumors, including those cancer types being investigated in the ongoing Phase 1b/2 PROCEADE-PanTumor study (NCT06710132). More mature data for PROCEADE-CRC-01 and details on the design for the PROCEADE-PanTumor study investigating precemtabart tocentecan in patients with locally advanced/metastatic non-small cell lung, gastric, gastroesophageal junction or pancreatic cancer will be presented during the annual meeting. (Abstracts 3038 & TPS3165)
Avelumab in advanced bladder cancer
Interim results from the Phase 2 JAVELIN Bladder Medley trial (NCT05327530) will be presented, focusing on the efficacy of avelumab in combination with the anti-Trop-2 ADC sacituzumab govitecan (Trodelvy®, Gilead Sciences) for patients with advanced urothelial carcinoma (UC) who are progression-free after first-line platinum-containing chemotherapy.
When used in the maintenance setting, the combination therapy significantly improved progression-free survival (PFS) versus avelumab alone (HR 0.49 [95% CI, 0.31-0.76]); median PFS was 11.17 months versus 3.75 months, respectively. Overall survival (OS) data were immature at the time of analysis. Treatment-related adverse events were more frequent in the combination group (97.3%) compared with avelumab monotherapy (63.9%).
The company also will present real-world evidence that reinforces the clinical trial findings from the Phase 3 JAVELIN Bladder 100 study (NCT02603432) of avelumab as a first-line maintenance therapy in patients with locally advanced/metastatic UC. The data highlight the effectiveness and safety of avelumab in routine clinical practice and heterogenous populations as well as the importance of personalized treatment decision-making.(Abstracts 4501, e16561, e23275, 9543)
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Presentations
| Title | Lead Author | Abstract | Session Information |
| Pimicotinib | |||
| Pimicotinib in tenosynovial giant cell tumor (TGCT): Efficacy, safety and patient-reported outcomes of Phase 3 MANEUVER study | Niu X | 11500 | Session Title: Sarcoma Date: Sunday, June 1, 2025 Session Time: 9:45 AM – 12:45 PM Presentation Time: 9:45 AM – 9:57 AM Location: S100a |
| Precemtabart tocentecan (M9140) | |||
| Precemtabart tocentecan (M9140), an anti-CEACAM5 ADC with exatecan payload, in patients with metastatic colorectal cancer (mCRC): Results from the dose optimization of the phase 1 PROCEADE CRC-01 study | Kopetz S | 3038 | Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Date: Monday, June 2, 2025 Session Time: 1:30 PM – 4:30 PM Location: Hall A |
| Avelumab (Bavencio®) | |||
| Avelumab + sacituzumab govitecan (SG) vs avelumab monotherapy as first-line (1L) maintenance treatment in patients (pts) with advanced urothelial carcinoma (aUC): Interim analysis from the JAVELIN Bladder Medley phase 2 trial | Hoffman-Censit J | 4501 | Session Title: Genitourinary Cancer—Kidney and Bladder Date: Sunday, June 1, 2025 Session Time: 9:45 AM – 12:45 PM Presentation Time: 9:57 AM – 10:09 AM Location: Hall D2 |
| Differences in patient (pt) characteristics and therapy choice across treatment (tx) groups in locally advanced or metastatic urothelial cancer (la/mUC) in the US: A survey on unmet patient needs | Milloy N | e16561 | Session Title: Publication Only: Genitourinary Cancer—Kidney and Bladder
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| Management and outcomes of rash, peripheral neuropathy (PN), and hyperglycemia (HG) during first-line (1L) treatment (tx) of locally advanced/metastatic urothelial cancer (la/mUC) in a real-world setting | Nizam A | e23275 | Session Title: Publication Only: Quality Care/Health Services Research |
| Real-world safety and effectiveness of avelumab in immune-compromised (IC) and non-IC patients with Merkel cell carcinoma (MCC): Results from a prospective German registry (MCC-TRIM) | Becker J | 9543
| Session Title: Publication Only: Genitourinary Cancer—Kidney and Bladder |
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Note:* EMD Serono is the Healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada
Note: ** Avelumab (Bavencio®) is a human anti-programmed death ligand-1 (PD-L1) antibody indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. The drug is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Clinical trials
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) – ClinicalTrials.gov ID NCT06710132
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) – ClinicalTrials.gov ID NCT05464030
Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER) – ClinicalTrials.gov ID NCT05804045
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley) – ClinicalTrials.gov ID NCT05327530
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) – ClinicalTrials.gov ID NCT02603432
Highlights or prescribing information
Sacituzumab govitecan (Trodelvy®, Gilead Sciences)[Prescribing Information]
Avelumab (Bavencio®; EMD Serono)[Prescribing Information]
Reference
[1] Sloot WN, Bertotti E, Onidi M, Paoletti A, Salve I, Tavano P, Vigna E, Mueller G. The Nonclinical Safety Assessment of a Novel Anti-CEACAM5 Antibody Exatecan Conjugate Predicts a Low Risk for Interstitial Lung Disease (ILD) in Patients-The Putative Mechanism Behind ILD. Int J Toxicol. 2025 Mar-Apr;44(2):153-169. doi: 10.1177/10915818241306039. Epub 2025 Jan 4. PMID: 39754485.
[2] Rao A, Patel MR. A review of avelumab in locally advanced and metastatic bladder cancer. Ther Adv Urol. 2019 Jan 30;11:1756287218823485. doi: 10.1177/1756287218823485. PMID: 30728859; PMCID: PMC6354303.
Featured image: Chicago Riverwalk, Chicago, IL, USA; Used under the Unsplash License
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