• 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 

Merck, a leading science and technology company, 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. “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 chemotherapy.[1]
• 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].