EMD Serono to Highlight Data at ESMO 2022 with Potential for Transformative Impact on Cancer Patients

Not intended for UK-based media Late-breaking data highlight 5-year survival results from Phase II study of the investigational IAP inhibitor xevinapant in the curative setting of unresected LA SCCHN Initial results of Phase II INSIGHT 2 study of TEPMETKO plus osimertinib as second-line treatment in EGFR-mutant NSCLC with MET amplification showed encouraging signs of clinical activity with this targeted, oral, chemo-sparing regimen First-in-human results for potential best-in-class investigational ATR inhibitor M1774 Rockland, MA, September 7, 2022 – EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany, in the US and Canada, today announced the latest research from the Company’s oncology portfolio and pipeline to be presented at this year’s European Society of Medical Oncology (ESMO) Annual Meeting, September 9-13, 2022. A total of 29 abstracts, including 5 late-breaking oral presentations and 2 additional mini-oral presentations, will feature data from company- and investigator-sponsored studies across six approved or investigational medicines in multiple tumor types. “Our ESMO 2022 data will highlight the strong potential of our innovative pipeline for patients with cancers with significant unmet needs,” said Victoria Zazulina, M.D., Head of Development Unit, Oncology, for the Healthcare business of Merck KGaA, Darmstadt, Germany. “From our IAP inhibitor xevinapant, studied in a curative setting in locally advanced head and neck cancer; through to new data in NSCLC patients with MET amplification and EGFR mutations; to our potentially best-in-class oral ATR inhibitor; we are focused on unlocking novel mechanisms of action that exploit the vulnerabilities of cancer.” The company’s late-breaking data at the congress feature five-year overall survival (OS) results from a Phase II study of the IAP (Inhibitor of Apoptosis Protein) inhibitor xevinapant in patients with unresected locally advanced squamous cell carcinoma of the head and neck [Mini Oral #LBA33]. Patients who received xevinapant plus chemoradiotherapy (CRT) had improved efficacy outcomes compared with those who received placebo with CRT. Additional late-breaking results include initial results from the Phase II INSIGHT 2 trial of TEPMETKO® (tepotinib) plus osimertinib in the treatment of patients with EGFR-mutant non-small cell lung cancer (NSCLC) with MET amplification (METamp) after progression on first-line treatment with osimertinib [Proffered Paper #LBA52]. The confirmed overall response rate (ORR) was 54.5% (95% CI, 32.2, 75.6) in 22 patients with METamp detected by FISH (MET GCN ≥5 and/or MET/CEP7 ≥2) in tissue biopsy who received tepotinib plus osimertinib and were followed for at least nine months, with six of 12 responders still on treatment. Among the 48 patients followed for at least three months, ORR was 45.8% (95% CI, 31.4, 60.8). The most common treatment-related adverse events of any grade in greater than 15% of patients were diarrhea (40.9%), peripheral edema (23.9%) and paronychia (17.0%). Further late-breaking data to be presented at ESMO 2022 include translational data for BAVENCIO® (avelumab) characterizing genomic biomarkers in peripheral blood from patients enrolled in the Phase III JAVELIN Bladder 100 trial [Proffered Paper #LBA74]. Additional key data to be presented: A mini-oral presentation from the first-in-human Phase I study of M1774, the Company’s potentially best-in-class potent and selective inhibitor of ataxia telangiectasia and Rad3-related (ATR), showing a favorable safety profile and pharmacologically relevant exposure in patients with advanced solid tumors (DDRiver Solid Tumors 301) [#457MO] exemplifying the Company’s commitment to advancing understanding of DNA Damage Response (DDR) inhibition mechanisms. Exploratory analyses from JAVELIN Bladder 100 that examine clinical outcomes in long-term responders with advanced urothelial carcinoma treated with BAVENCIO first-line maintenance for ≥12 months [#1760P]. Long-term follow-up data presented earlier this year reinforced the benefit of BAVENCIO plus best supportive care (BSC) in the first-line maintenance setting, with a continued improvement in OS versus BSC alone for patients with locally advanced or metastatic urothelial carcinoma whose tumors had not progressed on a platinum-based chemotherapy1. Results from cohorts A and C in the Phase II VISION trial demonstrated robust and durable efficacy in treatment-naïve and previously treated patients with metastatic NSCLC with METex 14-skipping. In previously treated patients, efficacy was observed regardless of prior therapies including IO and/or platinum-based CT [#985P]. Other company-sponsored events at ESMO 2022 include: Medical Symposia: From Complex to Simple: The Journey to Strategic Sequencing in the Management of mCRC (Friday, September 9, 6:00–7:30 PM CEST, 7.3Q Quimper Auditorium, Hall 7, Level 7.3) New Approaches to Optimize Treatment Outcomes in Advanced Urothelial Carcinoma (Saturday, September 10, 1:00-2:30 PM CEST, 7.3.U Urval Auditorium, Hall 7, Level 7.3) Evolution of SCCHN Treatment (Sunday, September 11, 6:30-8:00 PM CEST, 7.3.0 Orleans Auditorium, Hall 7, Level 7.3). Continuing Medical Education (CME): Navigating Treatment Decisions in Advanced NSCLC: Update on Molecular Testing and New Targeted Treatment Options (Friday, September 9, 10:15-11:45 AM CEST, Quimper Auditorium, Hall 7, Level 7.3) Select presentations (all times CEST): PIPELINE Title Lead Author Abstract # Session Title/Date/Time 5-year overall survival (OS) in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) treated with xevinapant+chemoradiotherapy (CRT) vs placebo+CRT in a randomized, phase 2 study J Bourhis LBA33Mini Oral Session: Head and Neck Cancer Saturday, 10 September 10:55 AM A First-in-Human Phase I Study of ATR Inhibitor M1774 in Patients with Advanced Solid Tumors (DDRiver Solid Tumors 301) TA Yap 457MO Mini Oral Session: Developmental Therapeutics Monday, 12 September 4:55 PM Phase 1 study of TIGIT inhibitor M6223 as monotherapy or in combination with bintrafusp alfa (BA) in patients (pts) with metastatic/locally advanced solid unresectable tumoursLL Siu750PInvestigational immunotherapy Monday, 12 September BAVENCIO (avelumab) Title Lead Author Abstract # Session Title/Date/Time Characterization of genomic biomarkers in peripheral blood (PB) from patients (pts) enrolled in the JAVELIN Bladder 100 trial of avelumab first-line (1L) maintenance in advanced urothelial carcinoma (aUC) T Powles LBA74Proffered Paper Session 1: GU tumours, non-prostate Saturday, 10 September 11:10 AM Avelumab versus standard second line treatment chemotherapy in metastatic colorectal cancer (mCRC) patients with microsatellite instability (MSI): the SAMCO-PRODIGE 54 randomised phase II trial J Taïeb LBA23 Proffered Paper Session 1: GI lower digestive Sunday, 11 September 11:15 AM Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): results from patients with ≥12 mos of treatment in JAVELIN Bladder 100J Aragon-Ching1760PUrothelial Cancer Monday, 12 September Preliminary results from AVENANCE, an ongoing, noninterventional real-world, ambispective study of avelumab first-line (1L) maintenance treatment in patients (pts) with locally advanced or metastatic urothelial carcinoma (la/mUC)P Barthélémy 1757PUrothelial Cancer Monday, 12 September Avelumab added to FOLFIRI plus cetuximab followed by avelumab maintenance in patients with previously untreated RAS wild-type colorectal cancer–The phase-II FIRE-6 (AIO KRK-0118)S Stintzing424PColorectal Cancer Sunday, 11 September TEPTMETKO (tepotinib) Title Lead Author Abstract # Session Title/Date/Time Tepotinib+osimertinib for EGFR-mutant(m) NSCLC after progression on first-line (1L) osimertinib due to MET amplification: Initial results from the INSIGHT 2 study J Mazieres LBA52Proffered Paper Session: NSCLC, metastatic Sunday, 11 September 2:55 PM Tepotinib outcomes according to prior therapies in patients with METexon14 (METex14) skipping NSCLC E Smit 985P NSCLC, metastatic Monday, 12 September

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