On December 28, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on November 4, 2020, for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for the PARP inhibitor, Lynparza (generic name: olaparib) for the treatment of BRCA-mutated castrate-resistant prostate cancer with distant metastasis (mCRPC) (Press release, Chugai, DEC 28, 2020, View Source [SID1234573270]).

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"We are pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic of olaparib for prostate cancer," said Dr. Osamu Okuda, Chugai’s President and COO. "In addition to ovarian cancer, the significance of detecting BRCA1/2 alterations and selecting the appropriate treatment for prostate cancer has become apparent. Through FoundationOne CDx Cancer Genomic Profile, we are committed to promoting the appropriate use of comprehensive genomic profiling to ensure that proper treatment will be provided to patients who may benefit from olaparib."

The approval aims to expand FoundationOne CDx Cancer Genomic Profile for use as a companion diagnostic to identify prostate cancer patients with BRCA1/2 alterations who could benefit from the treatment with olaparib whose disease progressed after treatment with enzalutamide or abiraterone by detecting BRCA1/2 gene alterations. The efficacy and safety of olaparib in mCRPC patients with BRCA1/2 alterations were investigated in the Phase III PROfound study and AstraZeneca K.K. received approval from the MHLW on December 25. Olaparib is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and MSD (Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., in the US and Canada).

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

Approval information The underlined part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About BRCA alterations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.1-4

Trademarks used or mentioned in this release are protected by laws.

On December 28, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed after failure of platinum-based chemotherapy (Press release, Janssen Pharmaceuticals, DEC 28, 2020, View Source [SID1234573292]). The application marks the first-ever regulatory submission in the EU for a treatment for patients with NSCLC that specifically targets EGFR exon 20 insertion mutations.1

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Amivantamab is an investigational, fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR and MET mutations and amplifications.2,3,4,5

"The EMA submission represents an important milestone in our commitment to develop innovative, targeted therapies like amivantamab for patients facing a lung cancer diagnosis," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "This is an important step forward in our drive towards improving outcomes for patients diagnosed with NSCLC who have EGFR exon 20 insertion mutations where there are no EMA-approved targeted treatments today."

The EMA submission for amivantamab is based on monotherapy data from the Phase 1 CHRYSALIS study, a multi-centre, open-label, multi-cohort study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib,* a novel third-generation EGFR tyrosine kinase inhibitor (TKI),6 in adult patients with advanced NSCLC.7 In the study, investigators assessed efficacy using overall response rate per Response Evaluation Criteria in Solid Tumours Version 1.1** (RECIST v1.1), clinical benefit rate, and duration of response and progression-free survival, as well as the safety profile of amivantamab.7,8 This data was also the basis of the submission of the Biologics License Application for amivantamab to the U.S. Food and Drug Administration (FDA) in December 2020. Early data about amivantamab as a monotherapy treatment in patients with NSCLC with EGFR exon 20 insertion mutations were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Abstract #9512).8

"Lung cancer is the biggest cause of cancer death in Europe and has one of the lowest five-year survival rates for patients with cancer.9 Given this significant unmet need, we are committed to improving outcomes for patients diagnosed with this complex disease," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "With today’s submission for amivantamab, we are one step closer to our goal of advancing novel therapeutics that will transform the trajectory of some of the most challenging diseases of our time, including lung cancer."

"Lung cancer is responsible for 20% of cancer deaths in Europe: more than breast and prostate cancer combined.9 Despite advances in treatment, there is still a high unmet need amongst patients with EGFR-mutated NSCLC, particularly in the exon 20 insertion mutation population due to poor response to treatments that work for other mutations,10" said Joaquín Casariego, M.D., Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag, S.A. "We are encouraged by the promising results of amivantamab which continue to demonstrate potential for providing a new treatment option for patients with advanced NSCLC with EGFR exon 20 insertion mutations.8 This submission is an important milestone, and we look forward to working closely with the EMA as the application process progresses."

EGFR mutations, which drive tumours by causing uncontrolled cancer cell growth and division,11 are some of the most common mutations in NSCLC.12 EGFR exon 20 insertion mutations are the third most prevalent primary EGFR mutation.13 However, EGFR exon 20 insertions are also often undetected.13 Next Generation Sequencing (NGS) is effective at detecting EGFR exon 20 insertions and broader use of NGS can help to detect these mutations.13 Cancer driven by EGFR exon 20 insertion mutations is generally insensitive to approved EGFR TKI treatments and has a worse prognosis compared with cancer driven by more common EGFR mutations, including exon 19 deletions/L858R substitutions.10 Patients with EGFR exon 20 insertion mutations have a median survival of 16 months,14 which is much lower than patients with EGFR exon 19 deletions or L858R substitutions, who have a median survival of 32-39 months.15

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

**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.

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.2,3,4,5 Amivantamab is pending regulatory review as a potential treatment for NSCLC patients with EGFR exon 20 insertion mutations after failure of platinum-based chemotherapy. The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.16

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.17,18 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.19 The five-year survival rate for patients with metastatic NSCLC is currently 24 percent.19

The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.20 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cells growth and division.11 EGFR mutations are present in 10 to 15 percent of Caucasian patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC adenocarcinoma.12 Estimated median overall survival for patients with NSCLC and EGFR exon 20 insertion mutations is shorter than in patients with more common EGFR mutations.14

On December 28, 2020 Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that it has entered into an exclusive agreement with Inceptua Group ("Inceptua") for the distribution and commercialization of Apealea (paclitaxel micellar) in Europe (Press release, LSK BioPharma, DEC 28, 2020, View Source [SID1234573271]). Apealea has been authorized by European regulatory authorities for use in the European Economic Area in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

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"We are very pleased to announce our partnership with Inceptua to make Apealea (paclitaxel micellar) available to patients with ovarian cancer in Europe," said Alex Kim, Chief Executive Officer of Elevar Therapeutics. "Apealea is the only non-Cremophor based paclitaxel treatment approved in Europe for ovarian cancer, providing a treatment option with a higher paclitaxel dose and shorter infusion time without mandatory premedication versus Cremophor-based paclitaxel. Inceptua’s proven capabilities to develop and commercialize oncology and orphan treatments in Europe make them the ideal partner to accelerate access to Apealea in this important region. This agreement further propels progress for Apealea development and commercialization, an important step in Elevar’s strategy to optimize the value of its portfolio in global markets."

Under the terms of the agreement, Inceptua will have exclusive rights to distribute and commercialize Apealea in Europe. These rights do not extend to the Nordic countries (Denmark, Finland, Norway, Sweden, Iceland).

"We are delighted to enter into this agreement with Elevar to commercialize Apealea (paclitaxel micellar) in Europe," said Stefan Fraenkel, Chief Executive Officer of Inceptua. "We believe there is great potential for Apealea to help patients with ovarian cancer who cannot tolerate paclitaxel formulated with Cremophor, and we look forward to leveraging our established sales force, distribution networks, and market access capabilities to bring this important treatment to patients and healthcare providers throughout Europe."

Apealea (paclitaxel micellar) is a non-Cremophor based formulation of paclitaxel. It received marketing authorization from the European Commission in 2018, which was the first approval in Europe for a non-Cremophor EL paclitaxel in ovarian cancer and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).

About Ovarian Cancer

Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs 1. Globally, it is the third most common cancer among women and has the highest mortality rate 2,3. Although ovarian cancer has a lower prevalence in comparison with breast cancer, it is three times more lethal, and it is predicted that, by the year 2040, the mortality rate of this cancer will rise significantly 4,5. About half of the women who are diagnosed with ovarian cancer are 63 years or older and many of these patients are predisposed to age-related comorbidities, such as diabetes, which can influence treatment response and prognosis 6.

About Apealea (paclitaxel micellar)

Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and esophageal cancer, as well as other types of solid tumor cancers. Cremophor EL, is a toxic formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel and is associated with allergic reactions. Apealea received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer.

On December 28, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that management will present at the 23rd Annual Needham Virtual Growth Conference on Wednesday, January 13, 2021 at 2:45 p.m. Eastern Time (Press release, Personalis, DEC 28, 2020, View Source [SID1234573293]).

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On December 28, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it has submitted a CTA (Clinical Trial Authorization) application to the relevant regulatory authorities to start a Phase II efficacy study of its wholly-owned CD40 targeting antibody mitazalimab (Press release, Alligator Bioscience, DEC 28, 2020, View Source [SID1234573273]).

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The upcoming Phase II study OPTIMIZE-1 is an open-label, multi-center study assessing the clinical efficacy of mitazalimab in combination with chemotherapy (mFolfirinox) in patients with metastatic pancreatic cancer. The OPTIMIZE-1 study will be performed at several clinics in Europe and encompass up to a total of 66 patients. Inclusion of the first patient is planned during the first half of 2021 and will begin with a run-in period to determine the best dose for the combination with chemotherapy.

"The CTA submission is an important milestone for Alligator, as we are now entering clinical Phase II for the first time. With best-in-class benchmark data presented for mitazalimab during the autumn, I believe that OPTIMIZE-1 has great potential to deliver robust efficacy results in pancreatic cancer", said Per Norlén, CEO of Alligator Bioscience.

The mitazalimab drug candidate has previously reported positive clinical data from two Phase I studies, one performed by Alligator, one performed by Janssen Biotech Inc., displaying a manageable safety profile as well as early signs of efficacy.