On April 27, 2021 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 2 in favor of maintaining accelerated approval of Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane , albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1, as determined by an FDA-approved test (Press release, Genentech, APR 27, 2021, View Source [SID1234578587]). Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts, though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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"People with triple-negative breast cancer have few treatment options, which is why today’s committee decision to recognize the importance of this Tecentriq combination is significant," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We are grateful to the FDA and ODAC for the open dialogue and look forward to continued collaboration to improve the lives of people with breast cancer."

The FDA’s Accelerated Approval Program allows for conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval.

Tecentriq was granted accelerated approval in March 2019 for the treatment of adults with PD-L1-positive, unresectable locally advanced or mTNBC based on the positive progression-free survival (PFS) results from the IMpassion130 study. Continued approval for this indication was contingent upon the results of IMpassion131, the PMR for the mTNBC indication. This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. As the clinically meaningful benefit demonstrated in the IMpassion130 study remains, Genentech looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication.

Genentech remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine approved for particularly difficult to treat cancers. Tecentriq’s extensive development program includes multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings.

Tomorrow, on April 28th, the ODAC will discuss Tecentriq’s accelerated approval for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy.

About triple-negative breast cancer

Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, close to 285,000 people in the United States will be diagnosed with invasive breast cancer, and more than 44,000 will die from the disease in 2021. Breast cancer is not one, but many diseases based on the biology of each tumor. In triple-negative breast cancer, tumor cells lack hormone receptors and do not have excess HER2 protein. Approximately 15 percent of breast cancers are triple-negative based on the results of diagnostic tests. It is an aggressive form of the disease with few treatment options.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma.

Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:

They are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for "PD-L1", or
They are not able to take chemotherapy that contains any platinum regardless of the levels of "PD-L1" status
The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as the first treatment in patients with lung cancer if:

Their cancer has spread or grown, and
Their cancer tests positive for "high PD-L1", and
Their tumor does not have an abnormal "EGFR" or "ALK" gene.
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:

Their cancer has spread or grown, and
Is a type of lung cancer called "non-squamous NSCLC", and
Their tumor does not have an abnormal "EGFR" or "ALK" gene.
Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:

Their cancer has spread or grown, and
Is a type of lung cancer called "non-squamous NSCLC", and
Their tumor does not have an abnormal "EGFR" or "ALK" gene.
Tecentriq may be used alone in patients with lung cancer if:

Their cancer has spread or grown, and
They have tried chemotherapy that contains platinum, and it did not work or is no longer working.
If a patient’s tumor has an abnormal "EGFR" or "ALK" gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:

Has spread or cannot be removed by surgery, and
Their cancer tests positive for "PD-L1".
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Tecentriq is not for use with the medicine paclitaxel (a different medicine than paclitaxel protein-bound) in patients with TNBC when their breast cancer has spread or cannot be removed by surgery.

A type of lung cancer called small cell lung cancer (SCLC). Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer:

is a type called "extensive-stage small cell lung cancer," which means that it has spread or grown.
A type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq may be used with the medicine bevacizumab in patients with HCC if:

Their cancer has spread or cannot be removed by surgery, and
They have not received other medicines by mouth or injection through their vein (IV) to treat their cancer.
A type of skin cancer called melanoma. Tecentriq may be used with the medicines cobimetinib and vemurafenib in patients with melanoma when their skin cancer:

has spread to other parts of the body or cannot be removed by surgery, and
has a certain type of abnormal "BRAF" gene. Healthcare providers will perform a test to make sure this Tecentriq combination is right for the patient.
It is not known if Tecentriq is safe and effective in children.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after treatment has ended.

Patients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including:

Lung problems

Cough
Shortness of breath
Chest pain
Intestinal problems

Diarrhea (loose stools) or more frequent bowel movements than usual
Stools that are black, tarry, sticky, or have blood or mucus
Severe stomach area (abdomen) pain or tenderness
Liver problems

Yellowing of the skin or the whites of the eyes
Severe nausea or vomiting
Pain on the right side of the stomach area (abdomen)
Dark urine (tea-colored)
Bleeding or bruising more easily than normal
Hormone gland problems

Headaches that will not go away or unusual headaches
Eye sensitivity to light
Eye problems
Rapid heartbeat
Increased sweating
Extreme tiredness
Weight gain or weight loss
Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Feeling more hungry or thirsty than usual
Urinating more often than usual
Hair loss
Feeling cold
Constipation
The voice gets deeper
Dizziness or fainting
Kidney problems

Decrease in the amount of urine
Blood in the urine
Swelling of ankles
Loss of appetite
Skin problems

Rash
Itching
Skin blistering or peeling
Painful sores or ulcers in mouth or nose, throat, or genital area
Fever or flu-like symptoms
Swollen lymph nodes
Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

Chills or shaking
Itching or rash
Flushing
Shortness of breath or wheezing
Dizziness
Feeling like passing out
Fever
Back or neck pain
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if a patient underwent transplantation either before or after being treated with Tecentriq. A patient’s healthcare provider will monitor them for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

Have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
Have received an organ transplant
Have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
Have received radiation treatment to their chest area
Have a condition that affects the nervous system, such as myasthenia gravis or Guillain-Barré syndrome
Are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
Should have a healthcare provider do a pregnancy test before they start treatment with Tecentriq.
Should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq.
Are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq.
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

Feeling tired or weak
Nausea
Cough
Shortness of breath
Decreased appetite
The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

Feeling tired or weak
Nausea
Hair loss
Constipation
Diarrhea
Decreased appetite
The most common side effects of Tecentriq when used in triple-negative breast cancer with paclitaxel protein-bound include:

Decrease in hemoglobin (anemia)
Decreased white blood cells
Hair loss
Tingling or numbness in hands and feet
Feeling tired
Nausea
Diarrhea
Constipation
Cough
Headache
Vomiting
Decreased appetite
The most common side effects of Tecentriq when used in hepatocellular carcinoma (HCC) with bevacizumab include:

High blood pressure
Feeling tired or weak
Too much protein in the urine
The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include:

Skin rash
Joint, muscle, or bone pain
Feeling tired or weak
Liver injury
Fever
Nausea
Itching
Swelling of legs or arms
Mouth swelling (sometimes with sores)
Low thyroid hormone levels
Sunburn or sun sensitivity
Tecentriq may cause fertility problems in females, which may affect their ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.

Please visit View Source for the Full Tecentriq Prescribing Information and Medication Guide for additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit View Source

On April 27, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788) for the treatment of adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC), as detected by an FDA-approved test, who have received prior platinum-based chemotherapy (Press release, Takeda, APR 27, 2021, View Source [SID1234578586]). Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations.

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"Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes," said Christopher Arendt, head, Oncology Therapeutic Area Unit, Takeda. "We are excited to be one step closer to offering mobocertinib as an effective oral therapy for NSCLC patients with EGFR Exon20 insertions that have received prior platinum-based chemotherapy and look forward to continuing conversations with regulatory agencies in the U.S. and around the globe."

The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial, which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC. The application was submitted under the FDA’s accelerated approval program. The review is being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international partners.

Takeda has established an Expanded Access Program (EAP) (NCT04535557) for patients in the U.S. who may be eligible to receive access to mobocertinib during the review of the NDA. Additional information about Takeda’s EAP is available here.

About Mobocertinib (TAK-788)

Mobocertinib is an investigational, first-in-class, oral 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 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 Center for Drug Evaluation (CDE) for locally advanced or metastatic NSCLC patients with EGFR Exon20 insertion mutations who have been previously treated with at least one prior systemic chemotherapy.

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, several expansion cohorts and an extension cohort in patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC).

The platinum-pretreated population efficacy analysis investigated 114 patients with EGFR Exon20 insertion+ mNSCLC who received prior platinum-based therapy in the Phase 1/2 trial and were treated with mobocertinib at the 160 mg once daily dose.

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 EGFR 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, including 3,000 in the U.S. alone.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.

On April 27, 2021 SQZ Biotechnologies (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas,reported that it will present new data on the company’s scaled cGMP cell therapy manufacturing program at the 2021 American Society for Gene and Cell Therapy Virtual Annual Meeting (ASGCT) (Free ASGCT Whitepaper) from May 11-14 (Press release, SQZ Biotech, APR 27, 2021, View Source [SID1234578585]). The company will also present findings on the performance advantages of cells engineered through its proprietary Cell Squeeze Technology.

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"There is tremendous therapeutic need for faster and more efficient delivery of impactful cell therapies to patients around the world," said Armon Sharei, PhD, Chief Executive Officer at SQZ Biotechnologies. "Through our manufacturing and therapeutic development programs, we strive to transform the current cell therapy paradigm and are excited to share our progress at ASGCT (Free ASGCT Whitepaper)."

Rapid, Scaled cGMP and Aseptic Manufacturing Program Data

Company scientists will present new data on its proprietary Cell Squeeze manufacturing technology demonstrating its ability to rapidly and reproducibly deliver cell therapy doses at scale. The presentation will show that the company’s cGMP and aseptic manufacturing program can process 10 billion cells per minute with greater than 90 percent cell viability. The company is delivering its first investigational drug (SQZ-PBMC-HPV) utilizing this core technology for its Phase 1 clinical trial in patients with Human Papillomavirus positive (HPV+) tumors.

"The company’s cell therapy manufacturing program has proven in our Phase 1 trial its ability to deliver reproducible investigational drug batches rapidly and at scale," said Howard Bernstein, MD, PhD, Chief Scientific Officer at SQZ Biotechnologies. "Our advances in cell therapy manufacturing will potentially enable multiple therapeutics across oncology, infectious disease, and immune disorders to be developed and delivered to a broad patient population."

Cell Performance Advantages

Additionally, in a poster presentation, company scientists assessed the use of Cell Squeeze technology to deliver pre-complexed CRISPR/Cas9 RNPs to achieve multiplex-edited primary human T cells. When comparing the functional effects of the Cell Squeeze technology to the commonly used electroporation approach, the authors found significant differences in transcriptional changes between the two treatments. Cells treated with electroporation corresponded with aberrant cytokine production, potentially resulting in premature T cell exhaustion. SQZ treated T cells, however, did not have disrupted transcriptional profiles or cytokine production and readily expanded post treatment with robustness similar to untreated cells.

"This work highlights the advantages of using the Cell Squeeze technology for cell engineering," said Jonathan Gilbert, PhD, Vice President of Exploratory Research at SQZ Biotechnologies. "We demonstrate preclinically a clear distinction in cell performance with the ability to achieve multiple, distinct gene edits with more viable and functional cells."

On April 27, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will participate in fireside chats at the following virtual investor conferences in May (Press release, Exelixis, APR 27, 2021, View Source [SID1234578584]):

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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

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7th Annual Truist Securities Life Sciences Summit: Exelixis is scheduled to present at 3:30pm EDT / 12:30pm PDT on Tuesday, May 4, 2021.
BofA Securities 2021 Health Care Conference: Exelixis is scheduled to present at 2:00pm EDT / 11:00am PDT on Tuesday, May 11, 2021.
RBC Capital Markets 2021 Global Healthcare Conference: Exelixis is scheduled to present at 3:05pm EDT / 12:05pm PDT on Wednesday, May 19, 2021.
To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for 14 days.

On April 27, 2021 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by ADC Therapeutics to be the exclusive specialty pharmacy partner for ZYNLONTA (loncastuximab tesirine-lpyl), a new intravenous therapy option for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high grade B-cell lymphoma (Press release, Onco360, APR 27, 2021, View Source [SID1234578583]).

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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

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"Onco360 is excited to be selected as a specialty pharmacy provider for ZYNLONTA patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "The recent approval of ZYNLONTA provides a new therapy option for heavily pre-treated DLBCL patients who have failed prior lines of therapy. As a provider of this key treatment, Onco360 will support the highly specialized needs of relapsed/refractory DLBCL patients and their physicians across the US."

According to the National Cancer Institute‘s (NCI) Surveillance, Epidemiology, and End Results (SEER) Program, approximately 81,560 patients will be diagnosed with Non-Hodgkin Lymphoma (NHL) in 2021 with a corresponding 20,720 deaths. According to the National Comprehensive Cancer Network (NCCN) Guidelines, DLBCL is the common type of NHL, representing approximately 32% of all NHL cases annually. According to NCI SEER data, DLBCL has a five-year overall survival (OS) of 63.9% when considering all stages of disease. Based on data from various clinical trials, up to 30% of DLBCL patients will experience disease relapse, necessitating subsequent lines of therapy.

ZYNLONTA is manufactured by ADC Therapeutics, a commercial-stage biotechnology company which strives to improve the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs). The FDA’s approval of ZYNLONTA comes as a result of the Phase II LOTIS-2 (NCT03589469) clinical trial which demonstrated a 48.3% overall response rate (ORR) for relapsed/refractory DLBCL patients who failed at least two prior systemic therapies who were treated with ZYNLONTA. For full prescribing information, visit ZYNLONTA.com