On September 14, 2021 Zai Lab Limited, an innovative commercial-stage biopharmaceutical company, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for investigational bemarituzumab (FPA144), for first-line treatment for patients with FGFR2b overexpressing and human epidermal growth factor receptor (HER2)-negative metastatic and locally advanced gastric and GEJ cancers in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin) (Press release, Zai Laboratory, SEP 14, 2021, View Source [SID1234633498]).

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"In granting Breakthrough Therapy Designation, we are pleased to see that the CDE recognizes the promise of bemarituzumab. In combination with chemotherapy, bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or GEJ cancer as a frontline therapy," said Alan Sandler, M.D., president and head of global development, oncology, at Zai Lab. "We look forward to working with regulatory authorities in China as we advance bemarituzumab into global, registrational studies."

The designation is supported by results from the Phase 2 FIGHT study, which evaluated bemarituzumab plus chemotherapy (modified FOLFOX6) versus chemotherapy alone in patients with FGFR2b overexpression, HER2-negative frontline advanced gastric or GEJ cancer. All three efficacy endpoints in the FIGHT trial – PFS, OS and ORR – achieved pre-specified statistical significance in the bemarituzumab arm compared to the placebo arm. Additional analysis showed a positive correlation between benefit and the prevalence of FGFR2b overexpression tumor cells, affirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target. The Breakthrough Therapy Designation was granted based upon this subset of patients, based on IHC testing, showing at least 10% of tumor cells overexpressing FGFR2b.

More than one million new gastric cancer cases are diagnosed annually, and approximately half of all gastric cancer cases occur in China1. Nearly 88% of patients with advanced gastric and GEJ cancers are HER2-negative, and approximately 30% of these patients present with FGFR2b overexpression.

The Breakthrough Therapy Designation review policy is designed to promote the research and creation of drugs with apparent clinical advantages, which are intended for the prevention or treatment of serious life-threatening diseases or diseases which severely impact the quality of life for which there is no existing treatment or where sufficient evidence indicates advantages of the novel drug over currently available treatment options. Drugs that have been granted the Breakthrough Therapy Designation are prioritized by the CDE in communications, and in receiving guidance to promote the drug development progress.

Source: (1) Globocan 2020.

About Bemarituzumab

Bemarituzumab (anti-FGFR2b), also called FPA144, is a potential first-in-class investigational targeted antibody that is designed to block fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Bemarituzumab is being developed in gastric and GEJ cancers as a targeted therapy for tumors that overexpress FGFR2b.

Zai Lab has an exclusive license to develop and commercialize bemarituzumab in Greater China. Zai Lab collaborated with Five Prime (later acquired by Amgen) on the Phase 2 FIGHT trial in Greater China.

Initiation of the registrational program of bemarituzumab by Amgen is planned for the fourth quarter of 2021. Planning is underway for bemarituzumab clinical studies in other solid tumors, including squamous NSCLC.

On September 14, 2021 Sanofi reported the completion of its acquisition of Translate Bio, further accelerating the company’s efforts to develop transformative vaccines and therapies using mRNA technology (Press release, Sanofi, SEP 14, 2021, View Source [SID1234587675]). The acquisition adds a critical pillar to the company’s mRNA Center of Excellence which aims to unlock the potential of next-generation mRNA vaccines and other strategic areas such as immunology, oncology, and rare diseases.

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The tender offer for all of the outstanding shares of Translate Bio common stock expired as scheduled at one minute after 11:59 p.m., Eastern Time, on Monday, September 13, 2021. The minimum tender condition and all of the other conditions to the offer have been satisfied and on September 14, 2021, Sanofi accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.

Following its acceptance of the tendered shares, Sanofi completed its acquisition of Translate Bio through the merger of a wholly owned subsidiary of Sanofi with and into Translate Bio, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Translate Bio continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi.

In connection with the merger, all Translate Bio shares not validly tendered in the tender offer have been converted into the right to receive the same $38 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of September 14, 2021, Translate Bio common stock will cease to be traded on the NASDAQ Global Select Stock Market.

Morgan Stanley & Co. International plc acted as exclusive financial advisor to Sanofi while Weil, Gotshal & Manges LLP acted as legal counsel. Centerview Partners acted as lead financial advisor to Translate Bio in the transaction, while Paul, Weiss, Rifkind, Wharton & Garrison LLP acted as legal counsel. Evercore also acted as a financial advisor in this transaction to Translate Bio. MTS Health Partners, LP also gave financial advice to Translate Bio.

On September 14, 2021 Specialised Therapeutics reported that AUSTRALIAN patients with an aggressive form of lung cancer (metastatic Small Cell Lung Cancer) can now access a new therapy that may improve outcomes (Press release, Specialised Therapeutics Asia, SEP 14, 2021, View Source [SID1234587691]).

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The therapy, ZEPZELCA (lurbinectedin) has been approved by the Therapeutic Goods Administration (TGA) "for the treatment of patients with metastatic small cell lung cancer (SCLC) that has progressed on or after prior platinum-containing therapy".1

This means patients who have failed other existing treatment options will now be able to access another line of therapy.

ZEPZELCA is the first new therapy approved by the TGA to treat second-line SCLC in more than two decades.

Australian lung cancer oncologist Professor Paul Mitchell from the Olivia Newton-John Cancer and Wellness and Research Centre said SCLC was particularly aggressive and more than two-thirds of patients were diagnosed with extensive stage disease. He said fewer than 5% of these patients currently survived more than five years post diagnosis. 3,4

"The new availability of ZEPZELCA will be welcomed by patients, families and the medical community, as we strive to improve patient outcomes for this disease," Professor Mitchell said.

"With this approval, we now have another option for patients who have progressed after prior platinum-based treatments. This provides an opportunity for them to continue treatment and potentially, improve outcomes."

The TGA approval of ZEPZELCA has been granted under a provisional regulatory pathway. The US Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA) collaborated via ‘Project Orbis’ to accelerate availability to Australian patients.

ZEPZELCA’s approval is based on clinical data from an open-label, multi-centre, single-arm phase II study in 105 adult patients with SCLC who had disease progression after treatment with platinum-based chemotherapy.2

The data, which appeared in The Lancet Oncology May 2020 issue, demonstrated that in patients with relapsed SCLC, ZEPZELCA provided an Overall Response Rate (ORR) of 35% and a median duration of response of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee (IRC).2

The provisional approval is the subject of a further confirmatory study in more than 700 patients with 2nd line SCLC including some Australian sites. This study is expected to be completed in 2025.

ZEPZELCA is being made available in Australia by the independent pharmaceutical Company, Specialised Therapeutics (ST), under exclusive license from international partner, PharmaMar.

ST Chief Executive Officer Mr Carlo Montagner said the approval of ZEPZELCA would potentially make a difference for around 400 Australian patients annually who had run out of treatment options.

"We are delighted to be able to provide a new therapy option for patients with this difficult to treat cancer," he said.

"While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment.

"Our mission has always been to provide therapies in areas of unmet need and SCLC is certainly one of these areas. We look forward to making a difference for these patients and their families."

PharmaMar president José María Fernández Sousa-Faro, PhD, said the Company was delighted Australian patients would now be provided access to ZEPZELCA.

"We are pleased to bring a new treatment choice to relapsed SCLC patients. "The accelerated approval of ZEPZELCA underscores its potential to fill an unmet need in this often-overlooked SCLC community."

ZEPZELCA is currently available in Australia via a Special Access Program.

Commercial supplies of ZEPZELCA will commence early 2022.

About Small Cell Lung Cancer (SCLC)

SCLC is a particularly aggressive type of lung cancer that represents approximately 10-15% of all lung cancers,3 accounting for more than 275,000 new cases worldwide every year. In Australia, around 1,900 patients are diagnosed annually with the disease,4 which is characterised by rapid growth, early dissemination that is often asymptomatic and with acquired resistance to drugs2. SCLC is staged into limited-stage or extensive-stage disease. Limited-stage disease is potentially curable with aggressive therapy consisting of concurrent chemoradiotherapy, prophylactic cranial irradiation, and occasionally, surgery. However, nearly two-thirds of SCLC patients have extensive-stage disease at diagnosis, which is not curable, and patients are currently treated with palliative intent, with a median survival of 7 to 11 months after diagnosis and with less than 5% survival at 2 years.5,6

About ZEPZELCA (lurbinectedin)

ZEPZELCA also known as PM1183, is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.1

ZEPZELCA 4 mg is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC) that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. ZEPZELCA is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of ZEPZELCA for this use.

About the Phase II Monotherapy Trial
The Phase II trial of ZEPZELCA was an open-label, single-arm study, which enrolled a total of 105 SCLC patients at 26 hospitals in six European countries and the U.S.2 In the trial, platinum-sensitive and platinum-resistant patients were treated with ZEPZELCA 3.2 mg/m2, administered as a 60-minute IV infusion repeated every 21 days until disease progression or unacceptable toxicity. The primary endpoint, ORR, was 35% and the median duration of response was 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an IRC).2 Serious adverse reactions in ≥3% of patients included pneumonia, febrile neutropenia, neutropenia, respiratory tract infection, anaemia, dyspnoea, and thrombocytopenia. ZEPZELCA was discontinued in 1.9% of patients and was delayed in 30.5% of patients due to an adverse reaction. Dose reductions for an adverse reaction occurred in 25 percent of patients.2

On September 14, 2021 Skyhawk Therapeutics, Inc. reported that Fidelity Management & Research Company LLC has led a $133 million oversubscribed investment round in Skyhawk, along with other major investors (Press release, Skyhawk Therapeutics, SEP 14, 2021, View Source [SID1234626568]). This brings total equity funding plus partnership capital in the Company to over $600 million thus far, with potential future milestones of over $20 billion plus ongoing royalties.

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"This investment round strengthens Skyhawk’s capacity to advance our internal pipeline of drug candidates deep into the clinic," said Bill Haney, co-founder and CEO of Skyhawk Therapeutics. "We are delighted that investors support our novel platform, a strong foundation from which to advance a series of our internal drugs for patients, even as we expand our work making drug candidates for our pharma collaborators."

On September 14, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that presentations on a series of abstracts highlighting updates on its oncology products and pipeline will be given at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2021, from September 16 to 21, 2021, including its in-house discovered lenvatinib mesylate (product name: LENVIMA, an orally available multi-kinase inhibitor, "lenvatinib") and eribulin mesylate (product name: HALAVEN, a halichondrin class microtubule dynamics inhibitor, "eribulin") (Press release, Eisai, SEP 14, 2021, View Source [SID1234587657]).

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At this congress, differences in outcomes by histology and prior therapy in the pivotal Phase 3 Study 309/KEYNOTE-775 trial, which compared the combination therapy of lenvatinib plus pembrolizumab (product name: KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), with TPC (Treatment of Physician’s Choice) in patients with advanced endometrial cancer, following at least one prior platinum-based regimen, will be presented as an oral presentation (Abstract No: 726MO). In addition, a subgroup analysis and safety update from the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581), which compared the combination of lenvatinib plus pembrolizumab versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC) will be presented as an e-poster presentation (Abstract No: 660P). Additionally, e-poster presentations will be given on the outcomes of early clinical studies on a liposomal formulation of eribulin plus nivolumab (Abstract No: 980P), a CREB-binding protein (CBP)/β-catenin interaction inhibitor E7386 (Abstract No: 473P) and a compound derived from total synthesis of halichondrin, E7130 (Abstract No: 545P）.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

Lenvatinib Abstract Topics
Product / Compound
Abstract Type
Abstract No. Presentation Topic
Lenvatinib+Pembrolizumab
mini oral

726MO
Outcomes by histology and prior therapy with lenvatinib plus pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer
(Study 309/KEYNOTE-775)

September 19 (Sun) 5:55 p.m. Central European Summer Time
Lenvatinib+Pembrolizumab
ePoster

660P
Phase 3 CLEAR Trial in Advanced Renal Cell Carcinoma (aRCC):
Outcomes in Subgroups and Toxicity Update

(Study 307/KEYNOTE-581)
Lenvatinib+Pembrolizumab
ePoster

506TiP
Pembrolizumab Plus Lenvatinib Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer (mCRC):

Phase 3 LEAP-017 Study
Lenvatinib+Pembrolizumab
ePoster

796P
Association Between Biomarkers and Clinical Outcomes of Lenvatinib (L) + Pembrolizumab (P) in Advanced Endometrial Cancer (EC): Results

From KEYNOTE-146/Study 111
Lenvatinib
ePoster

1746P
Health-related quality-of-life (HRQoL) analyses from Study 211-a phase 2 study in patients (pts) with radioiodine-refractory differentiated thyroid cancer (RR-DTC) treated with 2 starting doses of lenvatinib (LEN)

Lenvatinib
+anti-PD-1 antibody
ePoster

8P
The characterization of tumors associated with the antitumor activity of lenvatinib plus anti-PD-1 antibody combination therapy in a mouse syngeneic model panel

Eribulin Abstract Topics
Product / Compound
Abstract Type
Abstract No. Presentation Topic
Eriburin
ePoster

304P
Incidence and resolution of eribulin-induced peripheral neuropathy (IRENE) in patients with locally advanced or metastatic breast cancer

(IRENE/Study 504)
Eriburin liposomal formulation
+Nivolumab
ePoster

980P
Phase 1b study of a liposomal formulation of eribulin (E7389-LF) + nivolumab (Nivo) in patients (pts) with advanced solid tumors

(Study 120)

Other Development Products Abstract Topics
Product / Compound
Abstract Type
Abstract No. Presentation Topic
E7386
ePoster

473P
A phase 1 study of E7386, a CREB-binding protein (CBP)/β-catenin interaction inhibitor, in patients with advanced solid tumors including colorectal cancer (CRC)

(Study 103)
E7130
ePoster

545P
First-in-human (FIH) study of E7130 in patients (pts) with advanced solid tumors: primary result of dose-escalation part

(Study 101)

Other Abstract Topics
Abstract Type
Abstract No. Presentation Topic
ePoster

954P
Comparison of medical costs and outcome between hepatectomy and radiofrequency ablation for hepatocellular carcinoma

(Real World Evidence in Japan)
ePoster

305P
Real World Health-related Quality of Life (HRQoL) among HER2-negative (HER2-) Advanced Breast Cancer (ABC) Patients in EU3 and US

ePoster

306P
Real World Study of Treatments Received and Treatment Satisfaction Among HER2- Advanced Breast Cancer (ABC) Patients in EU3 and US

1. About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA (lenvatinib). Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA (pembrolizumab), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.

In addition to ongoing clinical studies evaluating the KEYTRUDA plus LENVIMA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in 13 different tumor types across more than 20 clinical trials.

2. Eisai’s Focus on Cancer

Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.