Data at the 2022 ASCO Annual Meeting Highlight Genentech’s Continued Commitment to Innovation in Oncology and Personalized Healthcare

On May 24, 2022 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that new data from clinical trials of 18 approved and investigational medicines across more than 20 cancer types will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held June 3-7, 2022 (Press release, Genentech, MAY 24, 2022, View Source [SID1234614958]). Genentech and its partners will present clinical studies across medicines, comprehensive genomic tests, and real-world data at this year’s meeting.

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"At ASCO (Free ASCO Whitepaper) this year, progress from our portfolio, partnerships and collaborations showcase our commitment to advance innovation in cancer care," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We’re especially pleased to present data from our broad hematology portfolio, including pivotal data for glofitamab, a potential first-in-class bispecific antibody that may improve the lives of people with heavily pre-treated aggressive lymphoma."

Focusing on improving outcomes in non-Hodgkin lymphoma

New and updated data in non-Hodgkin lymphoma will be presented at ASCO (Free ASCO Whitepaper). This includes pivotal data from the Phase II NP30179 study investigating glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, in heavily pre-treated patients with diffuse large B-cell lymphoma (DLBCL). DLBCL is an aggressive form of lymphoma, where as many as 40% of patients will relapse, at which point treatment options are limited and survival is shortened. Glofitamab is part of Genentech’s broad bispecific antibody development program, which may offer a new immunotherapy-based approach to tackle a range of blood cancers. It is being investigated in several clinical trials including the STARGLO Phase III study, evaluating glofitamab in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) in combination with GemOx in autologous stem-cell transplant ineligible relapsed or refractory DLBCL. In addition, key findings from an analysis of the Asia subpopulation from the pivotal Phase III POLARIX study investigating Polivy (polatuzumab vedotin) in combination with MabThera/Rituxan plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with newly diagnosed DLBCL will be featured. Polivy plus R-CHP is the first treatment regimen to significantly improve outcomes in previously untreated DLBCL in more than 20 years, potentially transforming treatment for people with this disease.

Driving innovation in personalized cancer care

More than 20 new pieces of research from partnerships with Foundation Medicine will be presented, which continue to support innovation as well as progress in personalized cancer care. This includes new data from the Phase II Profiler02 study,* which investigates the use of a comprehensive genomic profiling testing panel from Foundation Medicine, with the aim of informing possible treatment decisions for patients based on their tumor’s unique genomic information.

Data from the imCORE network

Additionally, three abstracts from the Immunotherapy Centers Of Research Excellence (imCORE) Network will be presented at ASCO (Free ASCO Whitepaper): a Phase I study** investigating autogene cevumeran (an mRNA-based individualized neoantigen-specific immunotherapy [iNeST]***) in the adjuvant setting of pancreatic ductal adenocarcinoma; a data mining study** evaluating intermediate endpoints for survival in metastatic breast cancer in the real-world setting; and a study identifying mechanisms of acquired resistance to immune checkpoint blockade.**

imCORE is an academic-industry network for scientific collaboration. Established by Genentech and connecting experts from 26 leading institutions around the globe, imCORE is committed to advancing and accelerating cancer immunotherapy research. imCORE is an example of Genentech’s dedication to collaborating with the global cancer community to further understand cancer biology and immunology, help inform the development of potential future treatment, and transform patients’ lives.

Genentech’s data presented at ASCO (Free ASCO Whitepaper) will feature its efforts to drive innovation and commitment to health equity through delivery of pioneering medicines and personalized cancer care that together improve outcomes for every patient while reducing the cost to society, inclusive clinical trials that remove barriers to participation, partnerships that multiply our ability to address challenges in cancer care, and bringing innovation into earlier stages of disease to maximize a chance of cure.

Overview of key presentations featuring Genentech medicines

Medicine

Abstract title

Abstract number

Blood cancer

Glofitamab

Glofitamab in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and ≥2 prior therapies: Pivotal Phase II expansion results

#7500

Mosunetuzumab

CELESTIMO: a Phase III trial evaluating the efficacy and safety of mosunetuzumab plus lenalidomide versus rituximab plus lenalidomide in patients with relapsed or refractory follicular lymphoma who have received ≥1 line of systemic therapy

#TPS7588

Polivy

Asia subpopulation analysis from the Phase III POLARIX trial

#7558

Initial safety run-in results of the Phase III POLARGO trial: polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin in patients (pts) with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL)

#7551

Lung cancer

Tiragolumab

SKYSCRAPER-02: primary results of a Phase III, randomized, double-blind, placebo-controlled study of atezolizumab (atezo) plus carboplatin plus etoposide (CE) with or without tiragolumab (tira) in patients (pts) with untreated extensive-stage small cell lung cancer (ES-SCLC)

#LBA8507

Breast cancer

Giredestrant

Neoadjuvant giredestrant (GDC-9545) plus palbociclib (P) versus anastrozole (A) plus P in postmenopausal women with estrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+/HER2– eBC): final analysis of the randomized, open-label, international Phase 2 coopERA BC study

#589

Inavolisib

Long-term safety of inavolisib (GDC-0077) in an ongoing Phase 1/1b study evaluating monotherapy and in combination (combo) with palbociclib (palbo) and/or endocrine therapy in patients (pts) with PIK3CA-mutated, hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer (BC)

#1052

Tumor agnostic treatment and personalized healthcare

Rozlytrek

Efficacy/safety of entrectinib in patients (pts) with ROS1-positive (ROS1+) advanced/metastatic NSCLC from the Blood First Assay Screening Trial (BFAST)

#LBA9023

Rozlytrek

Trial in progress: a randomized Phase 3 study of entrectinib vs crizotinib in patients (pts) with locally advanced/metastatic ROS1 fusion-positive (fp) NSCLC with or without baseline CNS metastases (mets)

#TPS9141

Comprehensive genomic profiling

(IIS, Centre Léon Bérard)

Increasing targeted therapy options for patients with relapsed cancer with broader somatic gene panel analysis from the primary tumor: The Profiler02 randomized Phase II trial*

#3130

Comprehensive genomic profiling

Clinical and genomic characteristics of patients with durable benefit from immune checkpoint inhibitors (ICI) in advanced non-small cell lung cancer (aNSCLC)

#9048

Comprehensive genomic profiling

ctDNA Shed as a Tool to Select Immune Checkpoint Inhibitors (ICPI) with or without Chemotherapy for Patients (pts) with advanced Non-small Cell Lung Cancer (aNSCLC)

#9045

Comprehensive genomic profiling

Trial in progress: LCMC LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers

#TPS8596

Real world data

A real world (rw) evidence study quantifying the clinical value of multi-gene testing in early-stage lung adenocarcinoma (LUAD)

#8525

Real world data

Real world analysis of quantitative MET copy number (CN) as a biomarker in advanced NSCLC (aNSCLC)

#9123

Real world data

Ancestry-based differences in gene alterations in non-small cell lung cancer: real-world data using genetic ancestry analysis

#9125

imCORE,

ISR, Genentech

Identifying mechanisms of acquired immune escape from sequential, paired biopsies**

#2519

imCORE

ISR, Dana-Farber Cancer Institute

Real-World Progression-Free Survival (rwPFS) and Time to Next Line of Therapy (TTNT) as Intermediate Endpoints for Survival in Metastatic Breast Cancer: A Real World Experience**

#6520

imCORE

ISR, Memorial Sloan Kettering Cancer Center

Phase I Trial of Adjuvant Autogene Cevumeran, an Individualized mRNA Neoantigen Vaccine, for Pancreatic Ductal Adenocarcinoma**

#2516

* IIS, investigator-initiated study

** ISR, institution-sponsored research

*** jointly developed by Genentech and BioNTech

About Polivy (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL.

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least two prior therapies.

The accelerated approval of Polivy is based on a type of response rate. There are ongoing studies to confirm the clinical benefit of Polivy.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. A patient’s doctor may stop or adjust a patient’s treatment if any serious side effects occur. Patients must contact their healthcare team if there are any signs of these side effects.

Nerve problems in arms and legs: This may happen as early as after the first dose and may worsen with every dose. If a patient already has nerve pain, Polivy may make it worse. The patient’s doctor will monitor for signs and symptoms, such as changes in sense of touch, numbness or tingling in hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to walking patterns

Infusion-related reactions: A patient may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of the infusion
Infections: Patients should contact their healthcare team if they experience a fever of 100.4°F or higher, chills, cough, or pain during urination. Also, a patient’s doctor may give medication before giving Polivy, which may prevent some infections, and monitor blood counts throughout treatment with Polivy. Treatment with Polivy can cause severe low blood cell counts
Rare and serious brain infections: A patient’s doctor will monitor the patient closely for signs and symptoms of these types of infections. Patients should contact their doctor if they experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of the skin or the white part of the eyes. Patients may be at higher risk if they already have liver problems or are taking other medication
Side effects seen most often

The most common side effects during treatment were:

Low blood cell counts (platelets, red blood cells, white blood cells)
Nerve problems in arms and legs
Tiredness or lack of energy
Diarrhea
Nausea
Fever
Decreased appetite
Infections
Polivy may not be for everyone. A patient should talk to their doctor if they are:

Pregnant or may be pregnant: Data have shown that Polivy may harm an unborn baby
Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for at least 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for at least 5 months after their last Polivy treatment
Breastfeeding: Women should not breastfeed while taking Polivy and for at least 2 months after the last dose
These may not be all the side effects. Patients should talk to their healthcare provider for more information about the benefits and risks of Polivy treatment.

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 Prescribing Information for additional Important Safety Information.

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 lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as a treatment for their lung cancer:
to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and
they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and
their cancer tests positive for "PD-L1".
Tecentriq may be used alone as their first treatment when their lung 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 their first treatment when their lung cancer:
has spread or grown, and
is a type 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 their first treatment when their lung cancer:
has spread or grown, and
is a type called "non-squamous NSCLC," and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may also be used when their lung cancer:
has spread or grown, and
they have tried chemotherapy that contains platinum, and it did not work or is no longer working
if their 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 lung cancer called small cell lung cancer (SCLC).

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer:
is a type called "extensive-stage small cell lung cancer," which means that it has spread or grown
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 their treatment or even after their 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 their 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
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
their voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

decrease in their amount of urine
blood in their urine
swelling of their 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 patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor 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 their 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:
A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
They 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 the 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
decreased appetite
nausea
cough
shortness of breath
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
Tecentriq may cause fertility problems in females, which may affect the 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 1-800-FDA-1088 or View Source

Report side effects to Genentech at 1-888-835-2555.

Please see View Source for full Prescribing Information and additional Important Safety Information.

About Rozlytrek

Rozlytrek (entrectinib) is an oral medicine for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC), as well as for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. Rozlytrek can block ROS1 and NTRK kinase activity and may result in the death of cancer cells with ROS1 or NTRK gene fusions.

Rozlytrek U.S. Indication (pronounced roz lye’ trek)

Rozlytrek is a prescription medicine used to treat:

Adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by an abnormal ROS1 gene
Adults and children 12 years and older with solid tumors (cancer) that:
are caused by certain abnormal NTRK genes and
have spread or if surgery to remove their cancer is likely to cause severe complications, and
there is no satisfactory alternative treatment option or the cancer grew or spread on other treatment
It is not known if Rozlytrek is safe and effective for use in children less than 12 years of age.

Rozlytrek was approved in NTRK gene fusion-positive solid tumors through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm benefit of Rozlytrek for this use.

Important Safety Information

Rozlytrek may cause serious side effects, including:

Congestive heart failure. Rozlytrek may cause congestive heart failure or make the congestive heart failure that a patient already has worse. Patients should tell their healthcare provider right away if they have any of the following signs and symptoms of congestive heart failure:

● persistent coughing or wheezing

● increasing shortness of breath


● trouble breathing when lying down

● tiredness, weakness, or fatigue


● sudden weight gain

● swelling in ankles, feet, or legs

Central nervous system (CNS) effects. Rozlytrek may cause dizziness, changes in mood, or may affect how a patient thinks and cause confusion, hallucinations, and problems with concentration, attention, memory, and sleep. Patients should tell their healthcare provider right away if they have any of these symptoms.
Bone fractures. Rozlytrek may increase the risk of bone fractures. Bone fractures may happen with or without a fall or other injury. Patients should tell their healthcare provider if they have pain, changes in movement, or bone abnormalities.
Liver problems (hepatotoxicity). A healthcare provider will do blood tests to check a patient’s liver function during treatment with Rozlytrek. Patients should tell their healthcare provider right away if they develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of the stomach area. A healthcare provider may temporarily stop treatment, decrease the dose, or permanently stop Rozlytrek if a patient develops liver problems with Rozlytrek.
Increased uric acid level in the blood (hyperuricemia). Rozlytrek may cause an excess of uric acid in the blood. A healthcare provider may do tests before and during a patient’s treatment with Rozlytrek to check the uric acid level in the blood. A healthcare provider may prescribe medications if a patient has high blood uric acid levels.
Changes in the electrical activity of the heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. A healthcare provider will do tests before and during treatment with Rozlytrek to check the electrical activity of the heart and body salts (electrolytes). Patients should tell their healthcare provider right away if they feel faint, lightheaded, dizzy, or feel their heart beating irregularly or fast while taking Rozlytrek. These may be symptoms related to QT prolongation.
Vision problems. Rozlytrek may cause vision problems. Healthcare providers may stop Rozlytrek and refer to an eye specialist if a patient develops severe vision problems during treatment with Rozlytrek. Patients should tell their healthcare provider right away if they have any loss of vision or any change in vision, including:

● double vision

● seeing flashes of light


● blurry vision

● light hurting the eyes


● new or increased floaters

Before taking Rozlytrek, patients should tell their healthcare provider about all their medical conditions, including if they:

have liver or kidney problems.
have any heart problems, including a condition called long QT syndrome.
have nervous system (neurological) problems.
have or have had eye or vision problems.
are pregnant or plan to become pregnant. Rozlytrek can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant during treatment with Rozlytrek or think they may be pregnant.
If patients are able to become pregnant, their healthcare provider will do a pregnancy test before they start treatment with Rozlytrek.
Females who are able to become pregnant should use effective birth control during treatment with Rozlytrek and for at least 5 weeks after the final dose.
Males who have female partners that are able to become pregnant should use effective birth control during treatment with Rozlytrek and for 3 months after the final dose.
are breastfeeding or plan to breastfeed. It is not known if Rozlytrek passes into breast milk. Do not breastfeed during treatment with Rozlytrek and for 7 days after the final dose of Rozlytrek. Patients should talk to their healthcare provider about the best way to feed their baby during this time.
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Certain other medicines may affect how Rozlytrek works causing side effects. Patients should know the medicines they take. Patients should keep a list of them to show to their healthcare provider and pharmacist when they get a new medicine.

The most common side effects of Rozlytrek include:

● tiredness

● nausea

● cough

● constipation

● abnormal touch sensation

● vomiting

● change in taste

● shortness of breath

● fever

● swelling

● muscle pain

● joint pain

● dizziness

● confusion, mental status changes, memory problems, and hallucinations

● vision changes

● diarrhea

These are not all the possible side effects of Rozlytrek. For more information, patients should ask their healthcare provider or pharmacist.

Patients should call their doctor for medical advice about side effects.

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

SpringWorks Therapeutics Announces Nirogacestat Achieved Primary and All Key Secondary Endpoints in Phase 3 DeFi Trial in Adult Patients with Progressing Desmoid Tumors

On May 24, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported positive topline results from the DeFi trial, a double-blind, placebo-controlled Phase 3 trial evaluating the efficacy, safety and tolerability of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors (Press release, SpringWorks Therapeutics, MAY 24, 2022, View Source [SID1234614978]).

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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!

The DeFi trial met its primary endpoint of improving progression-free survival (PFS), demonstrating a statistically significant improvement for nirogacestat over placebo, with a 71% reduction in the risk of disease progression (hazard ratio (HR) = 0.29 (95% CI: 0.15, 0.55); p < 0.001). In addition, the trial met all key secondary endpoints, with nirogacestat demonstrating statistically significant improvements as compared to placebo in objective response rate (ORR) and patient-reported outcomes (PROs). Nirogacestat was generally well tolerated with a manageable safety profile. The majority of women of childbearing potential had adverse events consistent with ovarian dysfunction. Other adverse events were generally consistent with previously reported data.

Additional data are expected to be presented at an upcoming medical conference in the second half of 2022 and SpringWorks plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2022.

"Desmoid tumors are aggressive soft-tissue tumors that can lead to severe negative outcomes for patients, including long-lasting pain, disfigurement, and amputation. In rare cases, when vital organs are impacted, desmoid tumors can also be life-threatening," said Saqib Islam, Chief Executive Officer of SpringWorks. "Today’s announcement represents a significant milestone towards our goal of bringing the first approved therapy to the desmoid tumor community. We look forward to sharing the DeFi trial data with the FDA and to presenting detailed study results at a medical meeting later this year."

Nirogacestat has received Orphan Drug Designation from the FDA for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

About the DeFi Trial

DeFi (NCT03785964) is an ongoing, global, randomized (1:1), double-blind, placebo-controlled Phase 3 trial evaluating the efficacy, safety and tolerability of nirogacestat in adult patients with progressing desmoid tumors. The study randomized 142 patients to receive 150 mg of nirogacestat or placebo twice daily. Key eligibility criteria included tumor progression by >20% as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) within 12 months prior to the first dose of study treatment. The primary endpoint is progression-free survival, as assessed by blinded independent central review. Secondary and exploratory endpoints include safety and tolerability measures, objective response rate (ORR), duration of response, changes in tumor volume assessed by magnetic resonance imaging (MRI), and changes in patient-reported outcomes (PROs).

About Desmoid Tumors

Desmoid tumors are rare, aggressive, locally invasive, and potentially morbid tumors of the soft tissues.1,2 While they do not metastasize, desmoid tumors are associated with a high rate of recurrence.2,3,4 Sometimes referred to as aggressive fibromatosis, or desmoid fibromatosis, these soft tissue tumors can be serious, debilitating, and, in rare cases when vital organs are impacted, they can be life-threatening.2,5

Desmoid tumors are most commonly diagnosed in patients between the ages of 20 to 44 years, with a two-to-three times higher prevalence in females.4,6,7 It is estimated that there are 1,000-1,650 new cases diagnosed per year in the United States.7,8

Historically, desmoid tumors were treated with surgical resection, but this approach has become less favored due to a high recurrence rate after surgery.1,4,9 There are currently no FDA-approved therapies for the treatment of desmoid tumors.

About Nirogacestat

Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

In addition, gamma secretase has been shown to directly cleave membrane-bound B cell maturation antigen (BCMA), resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has eight collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, three bispecific antibodies and a monoclonal antibody. SpringWorks has also formed research collaborations with Fred Hutchinson Cancer Research Center and Dana-Farber Cancer Institute to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA-directed therapies using a variety of preclinical multiple myeloma models.

Conference Call Details

SpringWorks will host a conference call and webcast today, Tuesday, May 24, 2022, at 8:30 a.m. Eastern Time to discuss the DeFi trial data. Participants can listen to the call by dialing +1 (844) 946-0285 (domestic) or +1 (602) 585-9676 (international) and providing the conference ID 2268304. A live webcast presentation can be accessed through the Investors & Media section of the Company’s website at View Source A replay of the webcast will be available on the SpringWorks website for a limited time following the event.

Genexine Appoints Industry Veteran Neil Warma as Chief Executive Officer to Accelerate Global Growth, Product Commercialization and Innovation

On May 24, 2022 Genexine (KOSDAQ: 095700) a publicly traded, clinical stage biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported the appointment of Neil Warma as its President and Chief Executive Officer (Press release, Genexine, MAY 24, 2022, View Source [SID1234614998]). Mr. Warma who has over 25 years of experience as a global entrepreneur, company builder and successful CEO will lead Genexine onto the world stage with a focus on advancing Genexine’s key products to market, expanding its pipeline and focusing on global drug development.

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Mr. Warma has been a successful healthcare entrepreneur for over 25 years having led and managed numerous biotechnology and pharmaceutical companies across the globe. From 2019-2022, Mr. Warma was the General Manager of I-Mab Biopharma U.S., (Nasdaq:IMAB) with offices in Shanghai, Beijing, Hangzhou, Guangzhou, Lishui and Hong Kong in China, and Maryland and San Diego, in the U.S., where he was a member of the executive team responsible for the Company’s expansion onto the global stage and for establishing I-Mab’s state-of-the-art research facilities in San Diego, California. From 2008-2017, Mr. Warma was President, CEO and Director of Opexa Therapeutics, Inc. (Nasdaq:OPXA), a publicly traded biopharmaceutical company developing novel cellular therapies for the treatment of autoimmune diseases, where he orchestrated global deals with Novartis and Merck Serono. From 2004-2007, he was President, CEO and Director of Viron Therapeutics, a private biotechnology company developing novel protein-based therapeutics for cardiovascular disease and transplantation. In 2000, Mr. Warma co-founded and later sold MedExact, a health-technology company dedicated to providing an interface between physicians and pharmaceutical companies. From 1992-2000, Mr. Warma held several key senior management roles at Novartis Pharmaceuticals at its corporate headquarters in Basel, Switzerland, in Pharma Policy and Global Marketing. Mr. Warma obtained an honors Bachelor of Science degree specializing in neuroscience from the University of Toronto and an International MBA from the Schulich School of Business at York University in Toronto. Mr. Warma currently serves on the Board of ProMIS Neurosciences (TSX:PMN) and the Biotechnology Innovation Organization (BIO). Mr. Warma has also been a member of the Board of Directors of Genexine since March 2021 and will continue to serve on the Board as an Executive Director.

"I am deeply honored to have been selected as Genexine’s new CEO by the Board of Directors," said Mr. Warma. "The Company has built a strong scientific foundation based on novel science and differentiated technology over several years. My focus will be to commercialize existing late stage products and further expand Genexine’s pipeline of life-saving products with a focus on first and best-in-class products. We will not only leverage our strength and position as a leading Korean biopharmaceutical company but will also expand our reach into the U.S. and Europe to increase our shareholder base and access new technology and top talent. Genexine has an exciting pipeline and with its global partners is conducting over 20 clinical trials, several in Phase 3 registrational trials. We expect to file several important BLAs in the next 1-3 years and commercialize our first products shortly thereafter."

"My goal is to introduce the biotech world to the top-class technology we have developed in Korea such that we can leverage our clinical data in the US and EU to reduce our development costs and speed the delivery of our products to the patient. We will also look to secure partnerships with global multinational pharmaceutical partners to share costs and leverage their substantial expertise. We are excited to be reporting some near term milestones coming up over the next several months with the planned announcement of Phase 1b/2 clinical data in our potential blockbuster product, GX-I7, the long-acting recombinant Interleukin-7 protein and Phase 2 data in our first-in-class DNA cancer vaccine being studied in cervical and head and neck cancers. These near term milestones should demonstrate our ability to execute and advance our products towards the market and, ultimately, to the patient," added Mr. Warma.

Aligos Therapeutics to Present at the Jefferies 2022 Healthcare Conference

On May 23, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos, will present in at the Jefferies Healthcare Conference on Wednesday, June 8, 2022, at 3:30 pm ET at the Marriot Marquis in New York City (Press release, Aligos Therapeutics, MAY 23, 2022, View Source [SID1234614941]).

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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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Jefferies Healthcare Conference

Date: Wednesday, June 8th, 2022
Time: 3:30 to 3:55 pm Eastern Time
Presenter: Lawrence Blatt, Ph.D., MBA, CEO of Aligos
Webcast: Registration Link – Click Here
A replay of the session will be available following the conference for 90-days through the Aligos investor section of the website View Source

The Aligos management team will also participate in investor 1×1 meetings during the conference. Please contact your Jefferies representative to schedule one-on-one meetings with Aligos during the conference.

Xcovery SHP2 Inhibitor IND Approved by US FDA

On May 23, 2022 Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted its investigational New Drug application (IND) of BPI-442096 , a small molecule Src homology region 2 domain-containing phosphatase 2 (SHP2) inhibitor, in solid tumors. Xcovery will initiate a phase I clinical trial in the United States to assess the tolerability, safety, and efficacy of BPI-442096 (Press release, Xcovery, MAY 23, 2022, View Source [SID1234614960]).

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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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BPI-442096 is a new molecular entity developed by Betta Pharmaceuticals in China. In preclinical studies, BPI-442096 demonstrated significant activity against a variety of cancer cells, including those with KRAS G12C mutation, KRAS G12D mutation, KRAS G12V mutation, KRAS G12A mutation, BRAF Class III mutation, NF1 LOF mutation, RTK mutation.

"I am very pleased to see BPI-442096 IND’s US approval," said Dr. Liu Fuqiang, Vice President of CMC at Betta Pharmaceuticals and at Xcovery. "Currently, there’s no SHP2 inhibitor drug on the market and we can fill the unmet need by bringing this compound to patients. With the earlier approved IND of BPI-361175, a 4th generation EGFR inhibitor, Betta and Xcovery are co-developing two very exciting assets in the US."

Giovanni Selvaggi, M.D., Xcovery’s CEO and CMO, commented, "The FDA’s acceptance of our INDs is an important validation of both Betta and Xcovery’s global capabilities in pre-clinical and clinical development in oncology. Together with BPI-361175, we can now establish our own small molecules pipeline against solid tumors."