FDA Approves Amgen And Allergan’s KANJINTI™ (trastuzumab-anns), A Biosimilar To Herceptin® (trastuzumab)

On June 13, 2019 Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) reported that the U.S. Food and Drug Administration (FDA) has approved KANJINTI (trastuzumab-anns) for all approved indications of the reference product, Herceptin (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (Press release, Amgen, JUN 13, 2019, View Source;p=RssLanding&cat=news&id=2401433 [SID1234537062]).

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"The FDA approval of KANJINTI is an important milestone for our biosimilars portfolio, providing an additional treatment option for patients across three types of cancer," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "KANJINTI is the third biosimilar from our portfolio to receive FDA approval, highlighting our long-term commitment to providing patients with serious illnesses access to high-quality biological therapies."

KANJINTI was proven to be highly similar to, and to have no clinically meaningful differences from, Herceptin based on a comprehensive totality of evidence which included extensive comparative analytical, pharmacokinetic and clinical data. At the time of approval, KANJINTI is the only trastuzumab biosimilar to incorporate the evaluation of a single transition in the clinical study, demonstrating similar safety and immunogenicity in patients who were previously on Herceptin.

"KANJINTI is the second of four biosimilars from Amgen and Allergan’s collaboration to be approved by the FDA," said David Nicholson, chief research and development officer at Allergan. "We are proud of the progress being made as we continuously strive to develop and deliver high-quality cancer therapies in collaboration with Amgen."

Amgen has a total of 10 biosimilars in its portfolio, three of which have been approved in the U.S. and three that are approved in the European Union (EU).

About KANJINTI (trastuzumab-anns) in the U.S.
KANJINTI is a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody. The active ingredient of KANJINTI is a humanized monoclonal antibody that has the same amino acid sequence, structure and function as trastuzumab. KANJINTI has the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab.

KANJINTI is currently not available commercially. This is not an offer for sale. The following information is derived from the approved label in the U.S.

In the U.S., KANJINTI is approved for:

Adjuvant Breast Cancer
KANJINTI is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
With docetaxel and carboplatin
As a single agent following multi-modality anthracycline-based therapy
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer
KANJINTI is indicated:

In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Metastatic Gastric Cancer
KANJINTI is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

KANJINTI U.S. Boxed WARNINGS and Important Safety Information

Boxed WARNINGS and Additional Important Safety Information
Cardiomyopathy

Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens
Evaluate left ventricular function in all patients prior to and during treatment with KANJINTI. Discontinue KANJINTI treatment in patients receiving adjuvant therapy and withhold KANJINTI in patients with metastatic disease for clinically significant decrease in left ventricular function
Infusion Reactions; Pulmonary Toxicity

Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt KANJINTI infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue KANJINTI for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
Embryo-Fetal Toxicity

Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Cardiomyopathy

Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed CHF died of cardiomyopathy
Trastuzumab can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
Trastuzumab can also cause asymptomatic decline in LVEF
Discontinue KANJINTI treatment in patients receiving adjuvant breast cancer therapy and withhold KANJINTI in patients with metastatic disease for clinically significant decrease in left ventricular function
Cardiac Monitoring

Evaluate cardiac function prior to and during treatment. For adjuvant breast cancer therapy, also evaluate cardiac function after completion of KANJINTI
Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
Monitor frequently for decreased left ventricular function during and after KANJINTI treatment
Monitor more frequently if KANJINTI is withheld for significant left ventricular cardiac dysfunction
Infusion Reactions

KANJINTI administration can result in serious and fatal infusion reactions
Symptoms usually occur during or within 24 hours of KANJINTI administration
Interrupt KANJINTI infusion for dyspnea or clinically significant hypotension
Monitor patients until symptoms completely resolve
Discontinue KANJINTI for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia
Embryo-Fetal Toxicity

Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Verify the pregnancy status of females of reproductive potential prior to the initiation of KANJINTI
Advise pregnant women and females of reproductive potential that exposure to KANJINTI during pregnancy or within 7 months prior to conception can result in fetal harm
Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of KANJINTI. Advise female patients to contact their healthcare provider with a known or suspected pregnancy
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for KANJINTI treatment and any potential adverse effects on the breastfed child from KANJINTI or from the underlying maternal condition
Pulmonary Toxicity

Trastuzumab products can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
Discontinue KANJINTI in patients experiencing pulmonary toxicity
Exacerbation of Chemotherapy-Induced Neutropenia

In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not
Most Common Adverse Reactions

The most common adverse reactions associated with trastuzumab products in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
The most common adverse reactions associated with trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at 1-800-772-6436.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS.

Syndax to Present at the JMP Securities Life Sciences Conference

On June 13, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, President and Chief Operating Officer of Syndax, will present at the JMP Securities Life Sciences Conference on Thursday, June 20, 2019 at 10:00 a.m. ET at the St. Regis New York (Press release, Syndax, JUN 13, 2019, View Source [SID1234537061]).

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A live webcast of the Company’s presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the events will also be available for a limited time.

Immutep Completes Recruitment of Initial Cohort in 1st Line NSCLC Patients for TACTI-002 Trial

On June 13, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that 17 patients have been enrolled into the first cohort of the first line non-small cell lung cancer (NSCLC) arm (Part A) of the Phase II TACTI-002 clinical trial (Press release, Immutep, JUN 13, 2019, View Source [SID1234537060]). This completes patient recruitment of the initial cohort of the study Part A. TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada).

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Patient enrollment for TACTI-002 commenced in early 2019, with the first patient being dosed in March 2019.

Under the Simon’s two-stage design, the initial cohort of first line NSCLC patients may be enlarged by a further 19 patients, if a pre-defined number of responses are observed. Ten study centers are now recruiting patients into the trial across the U.S., Europe and Australia, with three additional sites expected to commence recruitment in the coming months.

Dr Frederic Triebel, Immutep CSO and CMO, commented, "Efti has a unique mode of action. As an antigen presenting cell activator, it is successful in activating dendritic cells that process and present antigens for recognition by the T cell receptor on T lymphocytes. Efti is the only antigen presenting cell activator targeting MHC class II molecules currently in clinical development, setting it apart from other immuno-oncology therapies in the landscape.

It is very encouraging that we are achieving such positive traction with recruitment for our TACTI-002 study of efti, which commenced dosing patients just over three months ago. We expect to report the first data from this trial in mid-2019."

Recruitment is ongoing for the initial cohorts of the 2nd line NSCLC and 2nd line HNSCC of the Phase II TACTI-002 clinical trial. These cohorts may also be enlarged if a pre-defined number of responses are observed.

About TACTI-002 Phase II Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of Immutep’s lead product candidate eftilagimod alpha ("efti" or "IMP321") with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line. The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multi centre clinical study that is taking place in up to 13 study centres across the U.S., Europe and Australia.

Heron Therapeutics to Present at 2019 JMP Securities Life Sciences Conference

On June 13, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will present at the 2019 JMP Securities Life Sciences Conference on Wednesday, June 19, 2019 at 1:00 p.m. EDT at the St. Regis, New York (Press release, Heron Therapeutics, JUN 13, 2019, View Source [SID1234537059]).

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A live webcast of this presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

Agenus to Host Annual Meeting of Stockholders

On June 13, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune modulating antibodies, cancer vaccines, adjuvants and adoptive cell therapies1, reported investors and the general public to attend its annual meeting of stockholders on June 19, 2019 at 5:00 p.m. ET (Press release, Agenus, JUN 13, 2019, View Source [SID1234537058]). The meeting will be held at the Company’s headquarters located at 3 Forbes Road, Lexington, MA 02421. Registration for attendees will start at 4:30 p.m. ET.

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Conference Call and Webcast Information:
Date: Wednesday, June 19, 2019
Time: 5:00 p.m. ET
Domestic Dial-in Number: 1-844-492-3727
International Dial-in Number: 1-412-317-5118
Conference ID: Agenus

Live Webcast: accessible from the Company’s website at View Source or with this link View Source

A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.