On January 12, 2021 Taiho Oncology, Inc. and Servier reported that data for LONSURF (trifluridine and tipiracil) in previously treated patients with metastatic gastric cancer (mGC) and metastatic gastroesophageal junction adenocarcinoma (mGEJC) will be presented during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), taking place virtually from January 15-17, 2021 (Press release, Taiho, JAN 12, 2021, View Source [SID1234573931]). Key presentations include:

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The impact of prior therapies on outcomes with trifluridine/tipiracil (FTD/TPI) in the phase III TAGS trial: Kohei Shitara, MD, Chief, Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa (Abstract 247). Results will be shared online as a poster presentation on January 15, 2021. The abstract for this presentation is available on the ASCO (Free ASCO Whitepaper) GI website: View Source
Trifluridine/tipiracil outcomes in third- or later lines versus placebo in metastatic gastric cancer treatment: An exploratory subgroup analyses from the TAGS study: Josep Tabernero, MD, PhD, Head of Medical Oncology, Vall d’Hebron Barcelona Hospital, and Director, Vall d’Hebron Institute of Oncology (VHIO) (Abstract 229). Results will be shared online as a poster presentation on January 15, 2021. The abstract for this presentation is available on the ASCO (Free ASCO Whitepaper) GI website: View Source
Body weight loss (BWL) as a prognostic/predictive factor in previously treated patients (pts) with metastatic gastric or gastroesophageal junction cancer (mGC/GEJC): Post-hoc analyses of the phase III TAGS trial: Michele Ghidini, MD, PhD, Medical Oncologist, Department of Oncology, Azienda Ospedaliera di Cremona, Cremona, Italy (Abstract 476). Results will be shared online as a poster presentation on January 15, 2021. The abstract for this presentation is available on the ASCO (Free ASCO Whitepaper) GI website: View Source
Additional information can be found at Taiho Oncology’s virtual Medical Booth when the exhibit opens on January 15, 2021.

"We are pleased to facilitate the global collaboration of the TAGS investigators, which is reflected in these abstracts," said Karin Blakolmer, MD, MBA, Senior Vice President and Head of Medical Affairs, Taiho Oncology, Inc. "This partnership is critical as we continue to seek opportunities to optimize the use of LONSURF for patients suffering from advanced gastric cancer."

"These data will continue to broaden our knowledge of how LONSURF performs in patients living with metastatic gastric cancer and gastroesophageal junction adenocarcinoma following previous rounds of treatment," said François Druguet, Head of Global Medical Affairs Oncology, Servier.

The U.S. Food and Drug Administration (FDA) approved LONSURF in previously treated mGC and mGEJC in February 2019.1 The approval builds on the initial U.S. approval of LONSURF in 2015 for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.1

About TAGS
The TAGS (TAS-102 Gastric Study) trial was a Taiho-sponsored, global, pivotal Phase III, multinational, randomized, double-blind study evaluating LONSURF (trifluridine and tipiracil, FTD/TPI), plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer, including gastroesophageal junction cancer, refractory to standard treatments. The primary endpoint in the TAGS trial was overall survival (OS), and the main secondary endpoint measures included progression-free survival (PFS), safety and tolerability, as well as quality of life.

The TAGS trial enrolled 507 adult patients with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The study was conducted in 17 countries and 110 sites around the world.

About Metastatic Gastric Cancer
Gastric cancer, also known as stomach cancer, is the 15th most commonly diagnosed cancer in the U.S.2 In 2020, there were an estimated 27,600 new cases and 11,010 deaths.2 Approximately 36 percent of U.S. patients with gastric cancer are diagnosed at advanced disease.2 Metastatic gastric cancer (mGC) is associated with a five-year survival rate of about 5.5 percent.2

In the U.S., standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab), or irinotecan. After failure of first- and second-line therapies, subsequent treatment options are limited.

About Gastroesophageal Junction Cancer
Gastroesophageal junction cancer is a type of cancer that begins in cells located near the gastroesophageal junction, the area where the esophagus connects to the stomach.3 It remains a significant clinical problem that is increasing in incidence and is associated with a poor prognosis. The majority of patients present with advanced disease, and less than 50 percent undergo curative treatment.4

About LONSURF1
LONSURF is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.

Since 2015, Taiho Pharmaceutical and Servier have been in an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico, and Asia.

Indications and Use
LONSURF is indicated for the treatment of adult patients with:

metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy
metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Severe Myelosuppression:

LONSURF caused severe and life–threatening myelosuppression (Grade 3–4) consisting of neutropenia (38%), anemia (18%), thrombocytopenia (5%), and febrile neutropenia (3%). Two patients (0.2%) died due to neutropenic infection. A total of 12% of LONSURF–treated patients received granulocyte–colony stimulating factors. Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, absolute neutrophil count less than 500/mm3, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose as clinically indicated.

Embryo–Fetal Toxicity:

LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the final dose.

USE IN SPECIFIC POPULATIONS

Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breast–fed infant or the effects on milk production. Because of the potential for serious adverse reactions in breast–fed infants, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose.

Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.

Geriatric Use: Patients 65 years of age or over who received LONSURF had a higher incidence of the following compared to patients younger than 65 years: Grade 3 or 4 neutropenia (46% vs 32%), Grade 3 anemia (22% vs 16%), and Grade 3 or 4 thrombocytopenia (7% vs 4%).

Hepatic Impairment: Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin greater than 1.5 times ULN and any AST) hepatic impairment. Patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) were not studied. No adjustment to the starting dose of LONSURF is recommended for patients with mild hepatic impairment.

Renal Impairment: No adjustment to the starting dosage of LONSURF is recommended in patients with mild or moderate renal impairment (CLcr of 30 to 89 mL/min). Reduce the starting dose of LONSURF for patients with severe renal impairment (CLcr of 15 to 29 mL/min) to a recommended dosage of 20 mg/m2.

ADVERSE REACTIONS

Most Common Adverse Drug Reactions in Patients Treated With LONSURF (≥5%): The most common adverse drug reactions in LONSURF–treated patients vs placebo–treated patients with mCRC, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), infections (27% vs 16%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%). In metastatic gastric cancer or gastroesophageal junction (GEJ), the most common adverse drug reactions, respectively were, nausea (37% vs 32%), decreased appetite (34% vs 31%), vomiting (25% vs 20%), infections (23% vs 16%) and diarrhea (23% vs 14%).

Pulmonary emboli occurred more frequently in LONSURF–treated patients compared to placebo: in mCRC (2% vs 0%) and in metastatic gastric cancer and GEJ (3% vs 2%).

Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.

Laboratory Test Abnormalities in Patients Treated With LONSURF: The most common laboratory test abnormalities in LONSURF–treated patients vs placebo-treated patients with mCRC, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%). In metastatic gastric cancer or GEJ, the test abnormalities, respectively, were neutropenia (66% vs 4%), anemia (63% vs 38%), and thrombocytopenia (34% vs 9%).

On January 12, 2021 GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company’s proprietary NK cell engager (TriKE) technology platform reported the continuation of enrollment with patient 8 in its GTB-3550 clinical trial following the conclusion of a 30-day Covid-19 related pause in enrolling patients in all clinical trials currently being conducted at the University of Minnesota’s Masonic Cancer Center (Press release, GT Biopharma, JAN 12, 2021, View Source [SID1234573930]).

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Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible to participate in the GTB-3550 TriKE clinical trial (NCT03214666). The primary endpoint of the Study is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells.

GTB-3550 TriKE Demonstrates Clinical Benefit in Patients and 61.7% Reduction in Cancer Burden in patient 7

The GTB-3550 TriKE clinical trial commenced patient enrollment in February 2020 for the treatment of relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS). To date, seven patients have been enrolled in the clinical trial; two patients treated at 5 mcg/kg/day, two patients treated at 10 mcg/kg/day, two patients at 25 mcg/kg/day, and one patient treated at 50 mcg/kg/day. All seven patients have completed therapy. The results to date have been positive and the company continues to expand the enrollment.

Clinical Benefit Achieved and Reduction in Cancer Burden in HR-MDS Patient

A high-risk myelodysplastic syndromes (HR-MDS) patient had failed hypomethylating agent and Luspatercept therapies prior to being treated with GTB-3550 at 50mcg/kg/day (three consecutive 96-hour continuous infusions). The patient achieved bone marrow blast level reduction from 12% before GTB-3550 therapy to 4.6% post GTB-3550 therapy determined by morphological assessment (61.7% reduction in cancer cells), and had stable hematologic parameters including normal platelet counts throughout therapy. Following this single course of GTB-3550 therapy and the significant reduction in bone marrow blast levels, the patient demonstrated clinical benefit from GTB-3550 therapy, and qualified for and has received a hematopoietic stem cell transplant (HSCT). The only treatment with curative intent for a majority of elderly HR-MDS or relapsed/refractory AML patients is allogeneic hematopoietic stem cell transplant (HSCT). GTB-3550 TriKE therapy represents a novel, low intensity therapeutic option which has the potential to increase HSCT eligibility for elderly HR-MDS and relapsed/refractory AML patients.

Achievement of Stable Disease and Reduction in Cancer Burden in AML Patients

Two patients with relapsed/refractory acute myeloid leukemia who has previously failed prior therapies prior to being treated with GTB-3550; one patient treated at 5mcg/kg/day achieved stable disease and another patient treated at 25mcg/kg/day experienced a 33% reduction in bone marrow blast levels.

No Toxicities / Potent Native NK Cell Activation and Proliferation without Supplemental NK Cell Therapy

No signs of clinical immune activation, and no dose limiting toxicity such as cytokine release syndrome (CRS) or serious adverse events (SAEs) or fevers, tachycardia or constitutional symptoms have been observed in any patient treated to date with GTB-3550 TriKE. Correlative studies also showed no shedding of CD16 from patient’s NK cells, and potent NK cell activation, proliferation and target cell killing without the need for supplemental autologous NK cell therapy.

Targeted delivery of IL-15 to NK cells via GTB-3550 TriKE therapy showed preferential proliferation of NK cells, significantly less effect on CD8+ T-cells, and no observed toxicity at 25x the previous reported MTD for continuous infusion of recombinant human IL-15. GTB-3550 TriKE is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies,

Mr. Anthony Cataldo, Chairman and Chief Executive Officer of GT Biopharma commented "We are pleased to once again be allowed to proceed with patient enrollment now that the Covid-19 enrollment pause has been removed at the University of Minnesota’s Masonic Cancer Center."

About GTB-3550 TriKE

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment or relapsed/refractory acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (HR-MDS). GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill cancer cells.

On January 12, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that data published today in Cancer Prevention Research, a Journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), that expands on foundational clinical study findings to include a key younger population (Press release, Exact Sciences, JAN 12, 2021, View Source [SID1234573929]). Study results show that among average-risk adults between the ages of 45 and 49 Cologuard (mt-sD­­­­NA) demonstrated test specificity of 95.2% in participants with non-advanced precancerous lesions or negative findings at colonoscopy and 96.3% in only those with negative colonoscopy findings. These analyses support potential risk mitigation and cost prevention due to unnecessary diagnostic procedures when using Cologuard as a colorectal cancer screening tool in this younger population. ­­­­­

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Cologuard is a U.S. Food & Drug Administration (FDA)-approved, non-invasive stool DNA test for colorectal cancer for average-risk people. In September 2019, the FDA approved Cologuard for average-risk individuals beginning at age 45, expanding the Cologuard label to include this critical younger adult population.

Study is among the first to evaluate the use of a colorectal cancer screening method in patients between ages of 45-49.

"These new data support the critical role an effective, non-invasive option like Cologuard plays in screening people ages 45 to 49," said Kevin Conroy, chairman and CEO of Exact Sciences. "Cologuard may appeal to this younger screening population because they can collect sample at home, without missing work or undergoing bowel prep and anesthesia, and only those patients with a positive Cologuard will require a diagnostic colonoscopy."

In a previously published, large clinical study of nearly 10,000 patients 50 and older, Cologuard found 92% of colorectal cancers, including 94% in stages I and II. Specificity for this over 50 population was 87%.

Colorectal cancer is the second leading cause of cancer death for men and women in the United States, in part because many cancers go undetected until later stages when treatment is less effective. Colorectal cancer can be prevented or detected early through screening; however, approximately 44 million Americans remain unscreened, including an estimated 19 million between ages 45 and 49.

The incidence of colorectal cancer in people under the age of 50 has dramatically increased in the last 20 years. Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50. More than half of these cases were diagnosed at an advanced stage, stage III or stage IV, when survival rates are low.

"This study is among the first to evaluate the use of a colorectal cancer screening method in patients between the ages of 45 and 49," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "The American Cancer Society guidelines and the 2020 draft United States Preventive Services Task Force (USPSTF) guidelines now say that screening should begin at 45, and these data support the use of Cologuard as a first line screening option."

The prospective study included 816 evaluable participants who all completed a Cologuard test and underwent a colonoscopy. Participants were enrolled at 31 sites in the United States from November 2018 through June 2019. They completed Cologuard, followed by a screening colonoscopy within approximately 60 days of enrollment. Participants collected their sample for the Cologuard test prior to doing any bowel preparation necessary for the colonoscopy. All colonoscopies were performed blinded to the Cologuard results.

Specificity was the primary outcome and was measured in participants without colorectal cancer or advanced precancerous lesions and in the subgroup of participants with negative colonoscopic findings. None of the study participants had colorectal cancer, 49 had advanced precancerous lesions, 253 had non-advanced adenomas and 514 had negative colonoscopies. Specificity did not differ between men and women.

On January 12, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it will provide a preliminary update on its fourth-quarter and full-year 2020 financial results and the continued pace of its business recovery from the COVID-19 pandemic tomorrow, Jan. 13, 2021, during a fireside chat at 10 a.m. ET at the 39th Annual J.P. Morgan Healthcare Conference (Press release, Bausch Health, JAN 12, 2021, View Source [SID1234573927]).

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Bausch Health expects its revenue in the fourth quarter of 2020 will be greater than $2.20 billion. For the full year of 2020, the Company anticipates it will outperform the high end of its latest revenue guidance range of $7.80 – $8.00 billion.1

"Bausch Health’s preliminary fourth-quarter and full-year 2020 financial results demonstrate that our Company is continuing its business recovery from the effects of the COVID-19 pandemic driven by strong execution across our businesses. For the full year of 2020, we anticipate our revenue will outperform the high end of our latest revenue guidance range, and we also expect a strong finish to the year with regard to Adjusted EBITDA (non-GAAP)," said Joseph C. Papa, chairman and CEO, Bausch Health. "We look forward to releasing our full financial results for the fourth quarter and full year of 2020 next month."

Additionally, due to strong cash flow in the fourth quarter of 2020, Bausch Health expects to exceed $1 billion in cash generated from operations for the full year of 2020. In total, the Company repaid approximately $900 million of debt in 2020 from cash generated from operations and more efficient cash management, and has no debt maturities or mandatory amortization payments until 2024.

Bausch Health Will Publish Company Update Presentation on Jan. 13, 2021 at 7:00 a.m. ET
Bausch Health will publish a brief company update presentation tomorrow, Jan. 13, 2021, at 7 a.m. ET, that is designed to complement the remarks provided by management at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will provide an overview of the Company’s recent performance and offer insight into future catalysts for 2021 and beyond.

The presentation will be available on the Investor Relations page of the Bausch Health Companies Inc. website at: View Source A live webcast and audio archive of the fireside chat will also be available on the Investor Relations page of the Company’s website.

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

Thursday, January 28th EST / Friday, January 29th SST

Poster Displays

Abstract #3380

PAPILLON: Randomized Phase 3 Study of Amivantamab Plus Chemotherapy vs Chemotherapy Alone in EGFR Exon20ins NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #1247

Cardiac Safety Assessment of Lazertinib in Patients with EGFR Mutation-Positive Advanced NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #1405

A Phase 1/1b Study of Lazertinib as Monotherapy and in Combination with Amivantamab in Advanced EGFR-Mutated NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #3374

MARIPOSA: Randomized Phase 3 Study of First-Line Amivantamab + Lazertinib vs Osimertinib vs Lazertinib in EGFR-Mutant NSCLC

Thursday, January 28th EST / Friday, January 29th SST

Abstract #1271

Epidemiological and Clinical Burden of EGFR Exon 20 Insertion in Advanced NSCLC: Results of a Systematic Literature Review

Thursday, January 28th EST / Friday, January 29th SST

About Amivantamab
Amivantamab is an investigational, fully human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications.1,2,3,4 Companion diagnostics using Next Generation Sequencing, which are necessary to identify patients with EGFR exon 20 insertion mutations, have been an integral part of the development program for amivantamab. The bispecific antibody is being studied as a monotherapy in patients with EGFR exon 20 insertion mutations. Amivantamab is also being studied in combination with lazertinib, a third-generation tyrosine kinase inhibitor (TKI)13, in adult patients with advanced NSCLC.14 The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.

About Lazertinib
Lazertinib is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR.15 Interim safety and efficacy results from the lazertinib Phase 1-2 study were published in The Lancet Oncology in 2019. In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

About Non-Small Cell Lung Cancer (NSCLC)
Worldwide, lung cancer is one of the most common cancers, and NSCLC makes up 80 to 85 percent of all lung cancers.7,8 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.8 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.16 EGFR mutations are present in 10 to 15 percent of patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC.17 The five-year survival rate for all patients with metastatic NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent.18,19 Estimated median overall survival for patients with NSCLC and EGFR exon 20 insertion mutations is shorter than in patients with common EGFR mutations.16