Janssen to Highlight Commitment to Lung Cancer Science and Innovation with Eight Data Presentations at the International Association for the Study of Lung Cancer’s 2020 World Conference on Lung Cancer

On January 12, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that eight company-sponsored presentations, including two oral presentations, will be featured at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore taking place virtually January 28-31, 2021 (Press release, Johnson & Johnson, JAN 12, 2021, https://www.prnewswire.com/news-releases/janssen-to-highlight-commitment-to-lung-cancer-science-and-innovation-with-eight-data-presentations-at-the-international-association-for-the-study-of-lung-cancers-2020-world-conference-on-lung-cancer-301207007.html [SID1234573926]). The presentations include updated data from the Phase 1 CHRYSALIS study (NCT02609776) evaluating amivantamab in patients with NSCLC and EGFR exon 20 insertion mutations and two studies that characterize the high unmet need and lack of standard of care in patients with exon 20 insertion mutations and the underdiagnosis of these patients in real-world settings.

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Amivantamab is an investigational, fully human bispecific antibody that targets tumors by directing immune cell activity against tumors with activating and resistance EGFR mutations and mesenchymal epithelial transition factor (MET) mutations and amplifications.1,2,3,4 Janssen has filed regulatory submissions in the U.S. and Europe seeking approval of amivantamab for the treatment of patients with NSCLC and EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.5 These applications mark the first-ever regulatory submissions of a treatment for patients with NSCLC and EGFR exon 20 insertion mutations.6

"We see an important opportunity to improve the diagnosis and treatment of patients with EGFR-mutated non-small cell lung cancer, especially for individuals with exon 20 insertion mutations. To that end, we look forward to presenting data highlighting the potential of amivantamab in this patient population, and the importance of genetic testing to identify mutations that may impact treatment outcomes," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. "We are focused and committed to transforming the trajectory of lung cancer through improved diagnostics, novel therapeutics and interception strategies."

Lung cancer is one of the most common cancers and is the leading cause of cancer deaths worldwide, with NSCLC making up 80 to 85 percent of all lung cancers.7,8 Patients with EGFR exon 20 insertion mutations have a median survival of less than 17 months9, which is much shorter than patients with EGFR exon 19 deletions or L858R mutations, who have a median survival of 32-39 months on current therapies.10

Amivantamab Phase 1 CHRYSALIS Study Shows Promise for Patients with NSCLC and EGFR Exon 20 Insertion Mutations
New data from the Phase 1 CHRYSALIS study evaluating the safety and efficacy of amivantamab in patients with metastatic NSCLC and EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy will be presented as an oral presentation (Abstract #3031). Early results from the CHRYSALIS study were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Abstract #9512).11

Mini-Oral Presentation Underscores Unmet Need of Patients with EGFR Exon 20 Insertion Mutations
A mini-oral presentation based on real-world data will provide new insights into the differences in prognoses for patients with NSCLC and EGFR exon 20 insertion mutations compared to those with other EGFR mutations (Abstract #3390).

Real-World Datasets Spotlight Underdiagnosis for Patients with Lung Cancer with Genetic Alterations
Accurate identification of driver mutations is an important part of lung cancer diagnostic and staging processes.12 A new analysis of real-world genomic data that will be presented at the meeting (Abstract #3399) estimates that genetic tests using polymerase chain reaction (PCR) may miss up to 50 percent of tumors with EGFR exon 20 insertion mutations, suggesting significant underdiagnosis exists.

Further details about these data and the science that Janssen is advancing for patients with lung cancer will be made available throughout the IASLC 2020 WCLC via the Janssen Oncology Virtual Newsroom.

Company-sponsored abstracts to be presented at the meeting include:

Abstract No.

Title

Date/Time

Oral Presentation

Abstract #3031

Amivantamab, an EGFR-MET Bispecific Antibody, in EGFR Exon 20 Insertion Mutant Non-Small Cell Lung Cancer

Thursday, January 28th

10:55 pm – 11:05 pm EST / Friday, January 29th 11:55 am – 12:05 pm Singapore Standard Time (SST)

Mini-Oral Presentation

Abstract #3390

Comparative Clinical Outcomes for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutations and Common EGFR Mutations

Friday, January 29th

4:20 am – 4:25 am EST / Friday, January 29th 5:20 pm – 5:25 pm SST

Featured Poster

Abstract #3399

Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-Based Real-World Datasets