On June 4, 2021 The US Oncology Network (The Network), US Oncology Research and Ontada reported that Results from the first phase of the broad, collaborative MYLUNG Consortium research study in metastatic non-small cell lung cancer (mNSCLC) were released at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, US Oncology, JUN 4, 2021, View Source [SID1234583599]). The findings provide a close-up look at current biomarker testing rates and turnaround times for patients with mNSCLC treated in community practices within The Network. Most notably, Protocol 1 findings show that there are barriers that must be addressed as more than 80 percent of NSCLC is detected at Stage 4 and median time from diagnosis to first-line therapy is about five weeks.

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"The pace and development of treatments in non-small cell lung cancer is dramatic," said Makenzi Evangelist, MD, principal investigator for the MYLUNG Consortium’s Protocol 2 and oncologist with New York Oncology Hematology (NYOH), a practice in The Network. "There are already several targeted therapies to treat subsets of populations, and many more are in the pipeline that hold incredible potential. Unfortunately, barriers exist that prevent the necessary comprehensive biomarker testing that enables the use of these treatments. The MYLUNG Consortium study will be invaluable in identifying these obstacles and developing practical interventions that will allow us to fulfill the promise of precision medicine for patients with this difficult cancer."

Dr. Evangelist presented the findings during an oral presentation at ASCO (Free ASCO Whitepaper) titled, "Biomarker tissue journey among patients with untreated metastatic non-small cell lung cancer (mNSCLC) in The US Oncology Network community practices." (ASCO Abstract 9004).

The MYLUNG Consortium is a collaborative and innovative research study comprised of three protocols over a five-year period. Protocol 1, which was just completed, is a retrospective study of more than 3,500 patients with mNSCLC that investigated the following areas: testing rates for ALK, BRAF, EGFR, ROS1, and PD-L1 mutations; use of the full next-generation sequencing panel (NGS); time from NSCLC diagnosis to first-line therapy; turnaround times from biomarker orders to results; and time from NSCLC diagnosis to test results.

"We have derived significant insights from the study data so far," noted Sarah Alwardt, PhD, vice president of Operations for Ontada. "We are now able to see where there are gaps regarding targeted therapy. This real-world study showed that while most patients had at least one biomarker test result available prior to first-line therapy, less than 50 percent had five or more biomarkers tested. Consequently, a large percentage of patients were not given the opportunity for a targeted therapy."

Additionally, the median time from diagnosis to first-line therapy was about five weeks, a concern for patients anxiously waiting for treatment. Turnaround time from testing orders to results was about two weeks, indicating the need to get test results to physicians sooner so they have all critical information in front of them during development of the treatment plan. Next Generation Sequencing testing improved over time, suggesting comprehensive testing is increasing. Most of the population was diagnosed at advanced disease, with roughly over 80 percent detected at stage 4.

"Protocol 1 provides a look at what was happening retrospectively based on clinical data abstraction, allowing us to draw some early conclusions about historical baseline trends for testing patterns," noted Robert L. Coleman, MD, FACOG, FACS, chief scientific officer of US Oncology Research and the MYLUNG Consortium program principal investigator. "Retrospective studies like this help us understand where we are as far as testing behaviors, while also identifying gaps in the data that need to be filled with the prospective research the MYLUNG Consortium will address in the next protocols."

Data from Protocol 1 will be compared to the next phase of the MYLUNG Consortium study, Protocol 2, which will evaluate contemporary ordering practices and turnaround times prospectively. It will enroll about 1,000 patients from approximately 11 sites and will monitor the real-world patient journey from presentation through their first line of cancer therapy, focusing on how diagnostic biomarker information is obtained, utilized and operationalized in decision-making. Patients are currently being enrolled in this stage of the study.

The final phase of the study, Protocol 3, will serve as a platform upon which prospectively assessed interventional strategies in patient-engagement algorithms will be conducted. Up to 7,500 patients from approximately 20 participating sites will be recruited over a five-year period. Individual clinical trials will integrate findings from the previous protocols and explore new processes and associated outcomes. The goal is to help providers make the best treatment recommendations based on the data available while improving access to testing and appropriate therapies for patients with mNSCLC.

The MYLUNG Consortium study is enabled through a unique collaboration of various organizations and stakeholders working together across the spectrum of NSCLC drug development, therapy and care. The number of consortium participants continues to grow, all bringing unique perspectives to this innovative study. It brings together providers and researchers in The Network, US Oncology Research and Ontada with life sciences companies Amgen, AstraZeneca, Eli Lilly and Company, Genentech (a member of the Roche Group), and Mirati Therapeutics, Inc. Patient advocacy groups LUNGevity and GO2 Foundation for Lung Cancer are also participating, playing a key role in the study by keeping the focus on patients. Healthcare provider members include Illinois Cancer Specialists, Maryland Oncology Hematology, Minnesota Oncology, New York Oncology Hematology, Oncology Hematology Care, Rocky Mountain Cancer Centers, Southern Cancer Center, Virginia Cancer Specialists, Virginia Oncology Associates, Willamette Valley Cancer Institute and Research Center and Woodlands Medical Specialists.

Read more about the MYLUNG Consortium here. To schedule a media interview with one of the study investigators, contact Claire Crye at [email protected].

On June 4, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting (Press release, Cellectar Biosciences, JUN 4, 2021, View Source [SID1234583516]). In conjunction with the poster presentation, management will host a KOL call with the lead investigator for the company’s Phase 2 CLOVER-1 study of CLR 131 in patients with relapsed/refractory B-cell hematologic cancers, Dr. Sikander Ailawadhi, M.D. of the Mayo Clinic.

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The poster presentation entitled: Treatment Free Remission (TFR) and Overall Response Rate (ORR) Results in Patients with Relapsed/Refractory Waldenstrom’s Macroglobulinemia (WM) Treated with CLR 131 is an in-depth update of six patients from the company’s Phase 2a study of CLR 131 in Waldenstrom’s macroglobulinemia. To date, data have shown:

100% (6/6) overall response rate, 83.3% (5/6) major response rate and a 16.7% (1/6) complete response rate
Median time to initial response was 22 days after first infusion
Median time to major response, as defined as at least a 50% reduction in IgM, was 44 days after first infusion
Mean treatment free remission, as defined as the time from the last CLR 131 infusion to progression of disease, is 1.1 years and remains ongoing
Duration of response has not been reached, with 100% of the MYD88 wild type and high risk patients exceeding 8.5 months
Progression free survival (PFS) for both MYD88 wild type patients as well as the high-risk subgroup has not been reached after 18 months; PFS for multidrug refractory patients was 11 months
The most frequently reported treatment emergent adverse events were cytopenias
"CLR 131 is a differentiated targeted radiotherapy that has the potential to address patients with any mutational status, risk profile or multi-drug refractoriness in WM. Our pivotal study strategy will leverage these properties to address the treatment needs of patients, including the potential to provide durable response rates and meaningful treatment-free remission," said Dr. John Friend, chief medical officer at Cellectar. "CLR 131 has demonstrated impressive results including, to our knowledge, the only monotherapy to result in a complete response in this challenging WM patient set."

James Caruso, president and CEO of Cellectar added, "The data presented today from our ongoing Phase 2 CLOVER-1 study of CLR 131 in Waldenstrom’s further validates our clinical development program and gives us confidence in our goal of providing a new and better treatment with the potential to prolong and improve the quality of life for patients suffering from this devastating disease."

Management will host a conference call and webcast today, June 4, at 10:00 am ET featuring key opinion leader Dr. Sikander Ailawadhi. Dr. Ailawadhi is a Professor of Medicine, Lead, International Cancer Center, Division of Hematology/Oncology, Departments of Medicine and Cancer Biology at Mayo Clinic Florida. He was awarded the 2013 NCI Cancer Clinical Investigator Team Leadership Award as an Assistant Professor of Medicine at the USC Norris Comprehensive Cancer Center. Subsequently, he joined the Division of Hematology and Oncology at Mayo Clinic in Florida as a Senior Consultant in order pursue his career goal of clinical, translational and outcomes-based research in B-cell malignancies.

A replay of the call will be available on the Events page of company website following the live event.

About the Pivotal Trial of CLR 131 in Waldenstrom’s macroglobulinemia (WM)
The pivotal trial is designed as a global, non-comparator, single arm, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131. The study will enroll 50 WM patients. Patients in the trial will receive up to four doses of CLR 131 over two cycles (cycle one days 1, 15, and cycle two days 57, 71). The primary endpoint of the trial is response rate as defined as a partial response (a minimum of a 50% reduction in the biological marker IgM) or better in patients that receive a minimum total body dose of 60 mCi with secondary endpoints of treatment free survival, duration of response and progression free survival. An independent data monitoring committee (iDMC) will perform an interim safety and futility evaluation on the first 10 patients enrolled. The assessment will occur patient by patient and will conclude after the tenth patient is evaluated; there is no planned study stoppage.

About Waldenstrom’s macroglobulinemia
Waldenstrom’s macroglobulinemia (WM) is a rare and incurable disease defined by specific genotypic subtypes that defines patient responses and long-term outcomes. The annual incidence is 6,500 with prevalence of approximately 60,000 patients globally. WM is a lymphoma, or cancer of the lymphatic system. The disease occurs in a type of white blood cell called a B-lymphocyte or B-cell, which normally matures into a plasma cell whose job is to manufacture immunoglobulins (antibodies) to help the body fight infection. In WM, there is a malignant change to the B-cell in the late stages of maturing, and it continues to proliferate into a clone of identical cells, primarily in the bone marrow but also in the lymph nodes and other tissues and organs of the lymphatic system. These clonal cells over-produce an antibody of a specific class called IgM.

WM cells have characteristics of both cancerous B-lymphocytes (NHL) and plasma cells (multiple myeloma), and they are called lymphoplasmacytic cells. For that reason, WM is classified as a type of non-Hodgkin’s lymphoma called lymphoplasmacytic lymphoma (LPL). About 95% of LPL cases are WM; the remaining 5% do not secrete IgM and consequently are not classified as WM.

There is no standard treatment for WM. Several drugs have demonstrated activity either alone or in combinations, but only a single drug has received regulatory approval. Treatment is mainly focused on the control of symptoms and the prevention of organ damage. Front-line treatments for WM include rituximab alone or in combination with other agents. In the salvage therapy (second line or later) setting, ibrutinib, combinations of proteosome inhibitors and immunomodulatory drugs and stem cell transplantation are considered. Ibrutinib is the only drug to receive regulatory approval (2015) as a salvage therapy; in late 2019, it was approved for front-line treatment in combination with rituximab. Factors such as long-term cytopenias, age, hyper viscosity, the need for quick disease control, lymphadenopathy, co-morbidities, and IgM-related end-organ damage are key consideration in the choice of treatment.

On June 4, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, reported that updated data from the Company’s Phase 1 study of TJ004309 and Tecentriq (atezolizumab) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual annual meeting (Press release, Tracon Pharmaceuticals, JUN 4, 2021, View Source [SID1234583534]).

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In poster presentation 2511 entitled, "The safety, pharmacokinetics (PK), pharmacodynamics (PD) and clinical efficacy of uliledlimab (TJ004309), a differentiated CD73 antibody, in combination with atezolizumab in patients with advanced cancer," data were presented from 20 refractory cancer patients with advanced or metastatic solid tumors treated with the combination of uliledlimab and atezolizumab.

Key results included:

Uliledlimab was safe and well-tolerated up to 20 mg/kg every three weeks (Q3W) and 15 mg/kg once weekly (QW) as a monotherapy and in combination therapy with atezolizumab 1200 mg Q3W. No dose limiting toxicity was observed and the maximum tolerated dose was not reached.
Full saturation of circulating and cell-bound CD73 was achieved at doses ≥ 10 mg/kg.
Linear PK profile was observed at the doses ≥10 mg/kg following a single dose and the PK profile of uliledlimab supports Q3W dosing.
There was evidence of clinical activity (one complete response, two partial responses and three cases of stable disease) in both PD-(L)1 treatment naïve and refractory cancer patients, following treatment with uliledlimab and atezolizumab.
Higher tumor CD73 and PD-L1 co-expression were found in responders compared to non-responders.
"Uliledlimab was safe and refractory solid tumor patients benefitted following treatment with uliledlimab and atezolizumab," said Francisco Robert M.D., lead author and Professor of Medicine at the University of Alabama, Birmingham. "Further evaluation of uliledlimab in combination with checkpoint inhibitors in lung and ovarian cancers is warranted."

The poster is available on TRACON’s website at www.traconpharma.com.

About TJ004309

TJ004309 is a novel, humanized antibody discovered by I-Mab, against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TRACON is developing TJ004309 in collaboration with I-Mab Biopharma through one of our two strategic agreements with them, whereby we are responsible for the regulatory and clinical development of TJ004309 in the U.S. and Europe for this study. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On June 4, 2021 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported that updated immunogenicity and clinical response data from the GEN-009 Phase 1 trial that continue to validate the company’s unique and differentiated approach to identifying clinically meaningful immunotherapy targets through the proprietary ATLAS selection process (Press release, Genocea Biosciences, JUN 4, 2021, View Source [SID1234583551]). Data on the neoantigen vaccine combined with PD-1 inhibition in advanced solid tumors will be shared by Maura Gillison, M.D., Ph.D., Lead Investigator, MD Anderson Cancer Center, during a poster presentation (Abstract #2613) at the virtual 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021. The poster is available for on-demand viewing on the ASCO (Free ASCO Whitepaper) website and also posted to the Scientific Resources section of the Genocea website at View Source
Long-term results demonstrate that GEN-009 continues to generate broad immune responses against neoantigens that can lead to sustained clinical responses. In Part A of the study, designed to measure safety and immunogenicity only, eight patients with no measurable disease were vaccinated with GEN-009 as a monotherapy. Six of the eight patients continue without recurrence with a median follow up of 25 months post start of the vaccination. Notably, as previously reported, GEN-009 elicited T cell immune responses to 99% of the ATLAS-selected neoantigens, the highest seen across neoantigen vaccine programs.
In Part B, patients were enrolled at the initiation of a PD-1 checkpoint inhibitor (CPI)-based standard of care (SOC) regimen for advanced or metastatic disease; patients who were controlled on SOC and did not require alternate therapy are labeled CPI-sensitive, patients who required alternate therapy before vaccination are labeled CPI-refractory. Of the nine CPI-sensitive patients, the latest data show four patients experienced novel reduction in tumor volume post-GEN-009 dosing and achieved independent RECIST responses after vaccination, including three partial responses (PRs) and one complete response (CR). This is an increase from the two PRs and one CR previously reported at SITC (Free SITC Whitepaper) 2020. The remaining five CPI-sensitive patients all achieved disease stabilization. Across the CPI-sensitive cohort, the median duration without disease progression after initial GEN-009 vaccination was 15 months. Of the seven CPI-refractory patients, two achieved stable disease after initial GEN-009 vaccination for up to 10 months. GEN-009 has been well tolerated with only mild adverse events associated with the vaccine adjuvant.

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Expanded immunogenicity data from Part B of the study revealed that vaccine-specific T cell responses were detected ex vivo after the first dose of the vaccine and continued to rise with each subsequent dose. Vaccine-specific T cell responses remained significantly elevated over baseline and post-CPI, pre-vaccine timepoints for at least 6 months, showing persistence of the vaccine response. CPI-sensitive subjects had a greater number of neoantigens identified with ATLAS at baseline compared with patients in the CPI-refractory cohort, and also had evidence of epitope spread for CD8+ T cells post-dosing. Additionally, the magnitude of CD4+ T cell responses were greater for the CPI-refractory than CPI-sensitive subjects, despite a reduced proportion of peptides to which CD4+ T cell responses were measured, suggesting that the breadth and not the magnitude of response could be associated with favorable outcomes.
"We are very encouraged that GEN-009 can generate broad and diverse immune responses through ATLAS-selected neoantigens" said Thomas Davis, M.D., Chief Medical Officer of Genocea. "The deepened and durable responses in the CPI-sensitive patients and durable disease control in refractory patients are notable. We believe the cumulative long-term GEN-009 data continues to support our unique approach to identifying clinically meaningful immunotherapy targets and provides a strong foundation for our novel cell therapy candidate, GEN-011, which can target up to 30 ATLAS selected neoantigens and is currently in the clinic."
ASCO POSTER SESSION: Developmental Therapeutics – Immunotherapy
Abstract 2613: View Source
Title: Long term results from a phase 1 trial of GEN-009, a personalized neoantigen vaccine, combined with PD-1 inhibition in advanced solid tumors
GEN-009 is an adjuvanted personalized neoantigen vaccine being evaluated in eligible patients with advanced cancer who received standard-of-care (SOC) PD-1 checkpoint inhibitor (CPI) +/- chemotherapy during vaccine manufacturing and received 5 vaccine doses over 6 months along with continuation of PD-1 CPI. Genocea’s proprietary ATLAS platform selects tumor neoantigens for synthesis into GEN-009 peptides and identifies each patient’s own peripheral blood T cells and antigen-presenting cells. Patients who progressed prior to vaccination could receive alternate therapy followed by GEN-009 alone or in combination with a salvage regimen, as well as accelerated vaccine dosing. The contributions from GEN-009 are assessed using each patient as their own control based upon changes in tumor volume pre- versus post-vaccination.

On June 4, 2021 Novartis reported the first published mature overall survival (OS) and updated overall response rate (ORR) data following treatment with Tabrecta (capmatinib) in adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14)1-3 (Press release, Novartis, JUN 4, 2021, View Source [SID1234583567]). Data from the ongoing, pivotal, multi-cohort Phase II GEOMETRY mono-1 study will be presented today during the 2021 Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Meeting (Poster Discussion Session, Lung Cancer—Non-Small Cell Metastatic; June 4, 2021, 9:00 AM-10:00 AM CT; abstract 9020).

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"This new analysis further supports Tabrecta as a cornerstone targeted treatment for METex14 NSCLC patients and highlights the importance of biomarker testing," said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne, and lead investigator of the GEOMETRY study. "The impressive overall survival outcome and confirmed outstanding response in the first-line setting will help oncologists decide upon a therapeutic option for patients."

The analysis includes new data from the treatment-naïve (1L) expansion cohort 7 and previously-treated (2L+) cohort 6, and mature data from previously-reported cohorts, for a total of 160 patients1,2.

"The introduction of Tabrecta a year ago dramatically changed the treatment landscape for patients with METex14 NSCLC. Now we have further evidence that Tabrecta, the market-leading treatment specifically for METex14 NSCLC patients4, has the potential to help people live longer," said Jeff Legos, Senior Vice President, Head of Oncology Drug Development, Novartis Oncology.

The results presented today provide additional data on the efficacy of Tabrecta in both treatment-naïve and previously-treated patients with METex14 metastatic NSCLC 2:

Overall response rate (ORR) based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1:
67.9% (95% CI: 47.6, 84.1) and 65.6% (95% CI: 46.8, 81.4) among treatment-naïve patients (Cohort 5b; n= 28 and Cohort 7; n= 32 patients, respectively)
40.6% (95% CI: 28.9, 53.1) and 51.6% (95% CI: 33.1, 69.8) among previously-treated patients (Cohort 4; n= 69 and Cohort 6; n= 31 patients, respectively)
Median duration of response (DOR) based on BIRC assessment:
12.6 months (95% Cl: 5.6‑NE) and NE (95% CI: 5.5-NE) among treatment-naïve patients (Cohort 5b; n= 28 and Cohort 7; n= 32 patients, respectively)
9.7 months (95% Cl: 5.6‑13.0) and 8.4 months (95% Cl: 4.2‑NE) among previously-treated patients (Cohort 4; n= 69 and Cohort 6; n= 31 patients, respectively)
Overall survival (OS):
20.8 months (95% CI: 12.42, NE [not estimated]) among treatment-naïve patients (Cohort 5b; n= 28)
13.6 months (95% CI: 8.61, 22.24) among previously-treated patients (Cohort 4; n= 69)
Median OS for expansion Cohorts 6 & 7 are not reached
No new safety signals or unexpected safety findings were observed. Ninety-eight percent of subjects had at least one adverse event (AE) of any grade and 50.9% of subjects had at least one serious adverse event (SAE). Thirteen percent were suspected to be treatment-related. The most common adverse events (>20%, all grades) across all cohorts were peripheral edema, nausea, vomiting, increased blood creatinine, dyspnea, fatigue and decreased appetite. The majority of AEs were grade 3 or 42.

Currently, the five-year survival rate for lung cancer is less than 20%5, decreasing further when the disease is diagnosed at later stages6. Nearly one in three patients with metastatic NSCLC may have an actionable mutation7,8. METex14 has been reported to occur in 3%-4% of metastatic NSCLC cases9. Many patients with mutations that lead to METex14 are not diagnosed with NSCLC until their disease has progressed to later stages and often have poor prognosis10,11.

A separate analysis of patient-reported outcomes (PROs) evaluated cough, delayed time to lung symptom deterioration, and quality of life (QoL) in NSCLC patients with METex14 (abstract 9056)3.

Median time to definitive deterioration (TTDD) in global health status (GHS) was 16.6 months (95% CI: 9.7, NE) and 12.4 months (95% CI: 4.2, 19.4) in 1L and 2L+ patients, respectively
Median TTDD for cough and chest pain was NE in both 1L and 2L+ patients, and for dyspnea was 19.4 months (95% CI: 12.4, NE) and 22.1 months (95% CI: 9.9, NE), respectively
An exploratory post hoc analysis evaluated QLQ-LC13 symptoms (cough, chest pain, and dyspnea) over time for patients achieving a clinical response, as assessed by BIRC, found these symptoms improved at all cycles in patients achieving clinical complete response (CR) or partial response, while symptom worsening was seen in those with no clinical response
Additionally, a retrospective analysis of GEOMETRY mono-1 validates the clinical utility of liquid biopsy testing to identify METex14 positive patients for treatment with Tabrecta (Poster Session: Lung Cancer—Non-Small Cell Metastatic; abstract 9111)12.

Visit View Source for the latest information from Novartis, including our commitment to the Oncology community, and access to our ASCO (Free ASCO Whitepaper)21 Virtual Scientific Program data presentations (for registered participants).

About GEOMETRY mono-1
GEOMETRY mono-1 is a Phase II a multi-center, non-randomized, open-label, multi-cohort study in adult patients with EGFR wild-type, ALK-negative rearrangement, metastatic NSCLC harboring mutations that lead to MET exon-14 skipping who received capmatinib tablets 400 mg orally twice daily.

Patients were assigned to cohorts on the basis of MET status and previous lines of therapy13. The primary endpoint was overall response rate (ORR) based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The key secondary endpoint was duration of response (DOR) evaluated by BIRC.

About Tabrecta (capmatinib)
Tabrecta (capmatinib) is a kinase inhibitor that targets MET. Tabrecta was discovered by Incyte and licensed to Novartis in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications. In May 2020, Tabrecta was approved by the US Food and Drug Administration (FDA) for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14 as detected by an FDA-approved test. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

In June 2020, Tabrecta was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14 as detected by an FDA-approved test. Tabrecta was also approved in Hong Kong in February 2021 and Switzerland in April 2021.

Novartis and Lung Cancer
Lung cancer is the most common cancer worldwide, accounting for more than 2 million new cases diagnosed each year14. There are two main types of lung cancer – small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)15,16. NSCLC accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 2 million new cases each year14,16. More people die of lung cancer every year than any other cancer type14. Treatment options are limited for people with lung cancer who experience cancer growth or progression while on current standard of care treatments17-19.

Novartis is committed to developing best-in-class treatments for lung cancer patients around the world. With a focus on both targeted, personalized medicine and the role of newer core immuno-oncology therapies, the lung cancer drug development program at Novartis is among the most robust in the industry. Novartis research activities are informed by our long-term relationships with leading lung cancer thought leaders and patient advocates. With them, Novartis is committed to reimagining the treatment of lung cancer.

Indication
TABRECTA (capmatinib) tablets is a prescription medicine used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed by surgery (metastatic), and whose tumors have an abnormal mesenchymal-epithelial transition (MET) gene.

The effectiveness of TABRECTA in these patients is based on a study that measured 2 types of response to treatment (response rate and duration of response). There is no clinical information available to show if patients treated with TABRECTA live longer or if their symptoms improve. There are ongoing studies to find out how TABRECTA works over a longer period of time.

It is not known if TABRECTA is safe and effective in children.

Important Safety Information
TABRECTA may cause serious side effects, such as lung or breathing problems. TABRECTA may cause inflammation of the lungs during treatment that may lead to death. Patients should be advised to contact their health care provider right away if they develop any new or worsening symptoms, including cough, fever, trouble breathing, or shortness of breath.

TABRECTA may cause abnormal blood test results, which may be a sign of liver problems. Patients should be advised that their health care provider will do blood tests to check their liver before starting and during treatment with TABRECTA. Patients should be advised to contact their health care provider right away if they develop any signs and symptoms of liver problems including the skin or the white part of their eyes turning yellow (jaundice), dark or "tea-colored" urine, light-colored stools (bowel movements), confusion, loss of appetite for several days or longer, nausea and vomiting, pain, aching, or tenderness on the right side of the stomach area (abdomen), or weakness or swelling in the stomach area.

The skin may be sensitive to the sun (photosensitivity) during treatment with TABRECTA. Patients should be advised to use sunscreen or wear clothes that cover their skin during treatment with TABRECTA to limit direct sunlight exposure.

For women of reproductive potential, TABRECTA can harm their unborn baby. They should use an effective method of birth control during treatment with TABRECTA and for 1 week after the last dose. Men who have partners who can become pregnant should use effective birth control during treatment with TABRECTA and for 1 week after the last dose.

Before taking TABRECTA, patients should tell their health care provider about all their medical conditions, including if they have or have had lung or breathing problems other than lung cancer, have or have had liver problems, or if they are pregnant or plan to become pregnant, as TABRECTA can harm their unborn babies. Females who are able to become pregnant should have a pregnancy test before they start treatment with TABRECTA and should use effective birth control during treatment and for 1 week after the last dose of TABRECTA. Patients should be advised to talk to their health care provider about birth control choices that might be right for them during this time and to tell their health care provider right away if they become pregnant or think they may be pregnant during treatment with TABRECTA. Males who have female partners who can become pregnant should use effective birth control during treatment and for 1 week after their last dose of TABRECTA.

Patients should tell their health care provider about all the medicines they take or start taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of TABRECTA include swollen hands, ankles, or feet (peripheral edema); nausea and/or vomiting; tiredness and/or weakness (fatigue, asthenia); shortness of breath (dyspnea); loss of appetite; changes in bowel movements (diarrhea or constipation); cough; pain in the chest; fever (pyrexia); back pain; and decreased weight.