On January 28, 2021 Amgen (NASDAQ:AMGN) reported that it will report its fourth quarter and full year 2020 financial results on Tuesday, Feb. 2, 2021, after the close of the U.S. financial markets (Press release, Amgen, JAN 28, 2021, View Source [SID1234574394]). The announcement will be followed by a conference call with the investment community at 5 p.m. EST. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On January 28, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported new data from the Phase 1 CHRYSALIS study, which evaluated amivantamab in patients with metastatic or unresectable non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy (Press release, Johnson & Johnson, JAN 28, 2021, View Source [SID1234574392]).1 These data were presented for the first time in an oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore. The key findings showed robust activity and durable responses with a tolerable and manageable safety profile (Abstract #3031) in patients with NSCLC and EGFR exon 20 insertion mutations, a mutation for which no targeted therapies are currently approved.1,2,3

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Amivantamab is an investigational, fully-human EGFR and MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR and MET mutations and amplifications.4,5,6,7 Janssen has filed regulatory submissions in Europe and the U.S. 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.8,9 These applications mark the first-ever regulatory submissions for a treatment for patients with NSCLC and EGFR exon 20 insertion mutations.10

"There is a significant need for new treatment options for patients with NSCLC and EGFR exon 20 insertion mutations whose disease generally does not respond well to chemotherapy and the tyrosine kinase inhibitors used to treat other EGFR mutations," said Joshua K. Sabari, M.D., New York University Langone’s Perlmutter Cancer Centre and presenting investigator. "Results from the CHRYSALIS study presented today demonstrate the potential for amivantamab to address this critical unmet need and provide an important clinical benefit to patients."

In this analysis of the Phase 1 CHRYSALIS study, investigators assessed the efficacy and safety of amivantamab in patients with NSCLC and EGFR exon 20 insertion mutations, who had progressed on prior platinum-based chemotherapy, and were treated at the recommended Phase 2 dose (RP2D of 1050 mg [1400 mg for a patient weight of ≥80 kg] amivantamab).1 Disease response using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumours Version 1.1* (RECIST v1.1) was the primary endpoint.1 Other endpoints included duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS) and overall survival (OS).1,11 In the post-platinum efficacy cohort (n=81), the ORR as assessed by blinded independent central review was 40 percent (n=32; 95 percent CI, 29 – 51), with three patients (4 percent) having complete responses and 29 patients (36 percent) achieving partial responses (PR).1 Responses were durable with median duration of response of 11.1 months (95 percent CI, 6.9 – not reached), with 63 percent (n=20/32) having responses of at least six months or greater duration.1 Median PFS was 8.3 months (95 percent CI, 6.5 – 10.9) and median overall survival was 22.8 months (95 percent CI, 14.6 – not reached).1 The clinical benefit rate (≥PR or stable disease ≥11 weeks) was 74 percent (95 percent CI, 63 – 83).1

Among patients treated with amivantamab monotherapy (n=114) at the RP2D, the most common treatment-emergent adverse events (AEs) were rash (86 percent), infusion-related reactions (IRR; 66 percent) and paronychia (45 percent).1 Additional AEs were stomatitis (21 percent) and pruritus (17 percent).1 Grade ≥3 AEs were reported in 35 percent of patients, of which 16 percent were considered treatment-related with rash (4 percent) and IRR (3 percent) being most frequent.1 No treatment-related deaths were reported.1 The incidence of treatment-related AEs leading to dose reduction and discontinuation was 13 percent and 4 percent, respectively.1

"The data presented today further demonstrates the potential of amivantamab as a targeted therapy for a patient population which harbours a very resistant mutation and urgently needs new therapeutic options," said Joaquín Casariego, M.D., Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag, S.A. "We are committed to exploring further the role this innovation may have in addressing the unmet needs for many more patients and their families."

EGFR mutations, leading to uncontrolled cancer cell growth and division,12 are some of the most common mutations in NSCLC.13 EGFR exon 20 insertion mutations are the third most prevalent primary EGFR mutation and account for 3.7 – 10 percent of all EGFR mutations.3,14 These mutations, however, often go undetected because of the limited use of Next Generation Sequencing (NGS) testing.2,15 Additional Janssen-sponsored data presented in a featured poster at WCLC (Abstract #3399) showed that polymerase chain reaction (PCR) genetic testing is projected to miss 50 percent or more of tumours with EGFR exon 20 mutations.16

A Janssen-sponsored mini oral presentation at WCLC (Abstract #3390) highlights the need for new treatments, as cancer driven by EGFR exon 20 insertion mutations is generally insensitive to approved EGFR tyrosine kinase inhibitor (TKI) treatments and carries a worse prognosis compared with cancer driven by more common EGFR mutations, including exon 19 deletions/L858R substitutions.17 After 34 months median follow-up, patients with EGFR exon 20 insertion mutations experienced a 75 percent increased risk of death. The study also found that the five-year survival rate for exon 20 insertion mutations is 8 percent compared to 19 percent for other EGFR mutations.17

Janssen submitted a Marketing Authorisation Application (MAA) for amivantamab to the European Medicines Agency (EMA) in December 2020.9 The clinical development programme for amivantamab in untreated advanced EGFR-mutated NSCLC includes the Phase 3 MARIPOSA and PAPILLON combination trials.18,19

*RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumours, which is a standard way to measure how well solid tumours respond to treatment and is based on whether tumours shrink, stay the same, or get bigger.20

About the Phase 1 CHRYSALIS Study21

CHRYSALIS (NCT02609776) is an open-label, multicentre, first-in-human study to evaluate the safety, pharmacokinetics and preliminary efficacy of amivantamab as a monotherapy and in combinations including lazertinib or chemotherapy for the treatment of NSCLC.** The study will enrol 460 patients with advanced NSCLC. The study consists of two parts. The first part consists of amivantamab monotherapy and combination dose escalations and the second part is amivantamab monotherapy and combination dose escalations and expansions.

**In 2018, Janssen entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

About Amivantamab

Amivantamab is an investigational, fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications.4,5,6,7 Amivantamab 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 TKI,22 in adult patients with advanced NSCLC.21 The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.

About Non-Small Cell Lung Cancer (NSCLC)

In Europe, it is estimated that over 470,000 patients were diagnosed with lung cancer in 2018, with around 85 percent diagnosed with NSCLC.23,24 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.25 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.26 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.12 EGFR mutations are present in 10 to 15 percent of patients with NSCLC adenocarcinoma and occur in 40 to 50 percent of Asian patients.27 The five-year survival rate for all patients with metastatic NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent.28,29 Estimated median overall survival for patients with NSCLC and EGFR exon 20 insertion mutations is shorter than in patients with exon 19 deletions or L858R substitutions.28

On January 28, 2021 The Board of Directors of McKesson Corporation (NYSE: MCK) reported a regular dividend of 42 cents per share of common stock (Press release, McKesson, JAN 28, 2021, View Source [SID1234574391]). The dividend will be payable on April 1, 2021, to stockholders of record on March 2, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On January 28, 2021 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform the treatment of cancer, reported that the first patient has been injected in a phase I study evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer (Press release, Nanobiotix, JAN 28, 2021, View Source [SID1234574390]). The trial is being conducted at The University of Texas MD Anderson Cancer Center (MD Anderson) as part of an ongoing clinical collaboration.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Background and Opportunity

According to the World Health Organization, esophageal cancer is currently the sixth most common cause of cancer death in the world and is estimated to have caused over 508,585 deaths in 2018. The American Cancer Society estimates that in 2020 in the United States, there were approximately 18,440 new esophageal cancer cases diagnosed, and approximately 16,170 deaths due to esophageal cancer. Approximately 20% of patients survive esophageal cancer at least five years after diagnosis.

Phase I Study of NBTXR3 Activated by Radiotherapy with Concurrent Chemotherapy for Patients with Esophageal Cancer (MD Anderson Study 2020-0122)

This study is an open-label, single-arm, prospective phase I study consisting of two parts: (i) dose-escalation to determine the RP2D of NBTXR3 activated by radiotherapy with concurrent chemotherapy, and (ii) expansion at RP2D with toxicity monitoring.

The patient population will include adults (age ≥ 18 years) with stage II-III adenocarcinoma of the esophagus that are treatment-naïve and radiographically non-metastatic at screening. The number of participants enrolled will be determined based on the maximum number required to establish the RP2D of NBTXR3 activated by radiation therapy. Up to 24 subjects will be enrolled, including a maximum of 12 subjects for the dose-escalation part. Twelve additional subjects will be enrolled for the RP2D expansion part. Recruitment is ongoing and the planned enrollment period is 24 months.

Updates on this trial will be provided as they are made available by MD Anderson.

On January 28, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported new data from the Phase 1/2 trial of mobocertinib (TAK-788) orally administered in previously treated patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) will be presented as a late-breaking oral session at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) on Friday, January 29 SGT (Press release, Takeda, JAN 28, 2021, View Source [SID1234574389]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Results show mobocertinib demonstrated clinically meaningful responses and a noteworthy duration of response in patients with EGFR Exon20 insertion+ mNSCLC who received prior platinum-based therapy," said Pasi A. Jänne, M.D., Ph.D., Dana-Farber Cancer Institute. "These data are promising and provide further evidence for mobocertinib as a potential oral treatment for patients with EGFR Exon20 insertion+ mNSCLC, who are in critical need of targeted treatment options."

The analysis of platinum-pretreated patients included patients with EGFR Exon20 insertion+ mNSCLC who received prior platinum therapy from the Phase 1/2 trial. All patients were treated at the 160 mg once daily oral dose. Key findings from this population include:

Parameter

Results in Platinum-Pretreated Population (N=114)

Confirmed objective response rate (ORR) per investigator

35% (40/114; 95% CI 26-45)

Confirmed ORR per IRC

28% (32/114; 95% CI 20-37)

Median duration of response (DoR) per IRC

17.5 months (95% CI 7.4-20.3)

Median progression-free survival (PFS) per IRC

7.3 months (95% CI 5.5-9.2)

Disease control rate (DCR) per IRC

78% (89/114; 95% CI 69-85)

The safety profile observed was manageable. The most common treatment-related adverse events (TRAEs; ≥ 20%) in platinum-pretreated patients from the May data cutoff were diarrhea (90%), rash (45%), paronychia (34%), nausea (32%), decreased appetite (32%), dry skin (30%) and vomiting (30%). Grade ≥3 TRAEs (≥5%) included diarrhea (21%). Nineteen patients (17%) discontinued due to AEs, most commonly diarrhea (4%) and nausea (4%). The safety profile from the November data cutoff was consistent with that of the May data cutoff.

"The importance of advancing research for people living with EGFR Exon20 insertion+ mNSCLC – a complex and devastating disease with no approved targeted therapies – cannot be overstated, as existing treatment options provide limited benefit and patients often have poor survival outcomes," said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. "We’re proud of these positive results from mobocertinib, the first oral therapy designed to selectively target their disease, and we look forward to submitting data from the platinum-pretreated population analysis to the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the globe."

Mobocertinib is currently not approved for EGFR Exon20 insertion+ mNSCLC.

Takeda will host a briefing for analysts and investors on Friday, January 29, at 5:00 p.m. ET to discuss these data and the mobocertinib program. Please contact [email protected] for further details. Presentation slides and an archived replay of the webcast will be available at View Source

About the Phase 1/2 Trial

The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). The trial is comprised of a Phase 1 dose-escalation, evaluating mobocertinib as a monotherapy and in combination with chemotherapy, and a Phase 2 expansion, which includes seven different cohorts, as well as an extension cohort, investigating the anti-tumor activity of mobocertinib in various trial populations.

The platinum-pretreated population analysis investigated 114 patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC) who received prior platinum-based therapy from the escalation and expansion phases of the Phase 1/2 trial and were treated with mobocertinib at the 160 mg once daily dose.

The Phase 2 extension cohort, known as EXCLAIM, investigated 96 previously treated patients with EGFR Exon20 insertion+ mNSCLC who were treated with mobocertinib at the 160 mg once daily dose.

About Mobocertinib (TAK-788)

Mobocertinib, an oral therapy, is a potent, small-molecule tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with human EGFR 2 (HER2) mutations or EGFR mutations including Exon20 insertion mutations. In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. In October 2020, mobocertinib was designated as a Breakthrough Therapy in China by the Drug Review Center (CDE) for the same indication.

About EGFR Exon20 Insertion+ mNSCLC

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 1.8 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.1,2 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC) make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.3-7 This disease carries a worse prognosis than other EGFR mutations because there are currently no FDA-approved therapies that target Exon20 insertions, and current EGFR TKIs and chemotherapy provide limited benefit for these patients.

Takeda is committed to continuing research and development in EGFR Exon20 insertion+ mNSCLC with the hope of introducing a targeted treatment option for the approximately 30,000 patients diagnosed with the disease worldwide each year.3,4

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.