1stOncology™: Cancer Intelligence Service – Page 12437 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Gracell Announces Two Presentations at the Annual Meeting of American Society of Clinical Oncology (ASCO)

On May 29, 2020 Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell and gene therapy company, reported that two presentations were accepted at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (Press release, Gracell Biotechnologies, MAY 29, 2020, View Source [SID1234558770]).

Schedule your 30 min Free 1stOncology Demo!
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!

Both presentations can be found in the Development Therapeutics – Immunotherapy session, central on Gracell’s TruUCAR GC027 in relapsed or refractory T-cell acute lymphoblastic leukemia (r/r T-ALL) patients and EnhancedCAR GC008t in patients with advanced mesothelin-positive solid tumors.

"We are delighted to report on both TruUCAR GC027 in T-ALL and EnhancedCAR GC008t in solid tumors" said Dr. Martina Sersch, CMO of Gracell. "and glad to share safety and preliminary efficacy data on two of our exciting new CAR-T platform therapies with the scientific community at the ASCO (Free ASCO Whitepaper) annual meeting." Dr. William CAO, CEO of Gracell, added "Thanks to our highly efficient gene editing capability, CAR-T cells with PD-1 gene edited are generated to have enhanced capability of tumor control in inhibitory tumor microenvironment. We believe this strategy will improve CAR-T/TCR-T’s potency against solid tumors. Gracell carried out this strategy as early as 2017, upon our foundation. With two years’ preclinical and clinical investigations, we are very glad to see it showing first encouraging results in an effort to enhance CAR-T cells to combat solid tumors".

Session type: poster discussion
Abstract Title: Safety and efficacy results of GC027: The first-in-human, universal CAR-T cell therapy for adult relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL)
Abstract ID: 3013
Link: View Source

Session type: poster
Abstract Title: Phase I study of CRISPR-engineered CAR-T cells with PD-1 inactivation in treating mesothelin-positive solid tumors
Abstract ID: 3038
Link: View Source

About TruUCAR

TruUCAR is Gracell’s proprietary and patented platform technology, with selected genes being edited to avoid GvHD and immune rejection without using strong immunosuppressive drugs. In addition to T-ALL antigen, the platform technology can also be implemented for other targets of hematological malignancies.

About GC027

GC027 is an investigational, off-the-shelf CAR-T cell therapy, redirected to CD7 for the treatment of T cell malignancies. GC027 was manufactured from T cells of human leukocyte antigen (HLA) unmatched healthy donors using TruUCAR technology, which is expected to improve efficacy and reduce production time, available for off-the-shelf use in a timely manner.

About EnhancedCAR

EnhancedCAR is Gracell’s proprietary and patented platform technology, with selected genes edited to enhance immune cell performance in terms of killing efficiency, in vivo persistence, including selected PD-1 and TCR mediations. The technology can be implemented to many other targets with high editing precision and efficiency.

About GC008t

GC008t is an investigational, autologous CAR-T cell therapy, redirected to mesothelin with PD-1 disruption for the treatment of mesothelin-positive solid tumors. With PD-1 knocking out, GC008t is expected improve persistence and clinical efficacy.

About T-ALL

T – Lymphoblastic Leukemia (T-ALL) is an aggressive form of acute lymphoblastic leukemia, with a diffuse invasion of bone marrow and peripheral blood. In 2015, T-ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide. T-ALL compromises about 15%-20% of all children and adult acute lymphoblastic leukemia[1]. Current standard of care therapies for T-ALL are chemotherapy and stem cell transplantation. 40-50% of patients will experience relapse within two years following front line therapy with limited treatment options available[2][3]. Treatment of relapsed and refractory T-ALL remains a high unmet medical need.

About Mesothelin-positive Solid Tumors

Mesothelin, a cell surface antigen, has high expression to a broad spectrum of solid tumors while express low levels on normal cells. Mesothelin is believed as a good target for multiple solid tumors. The GC008t study enrolled patients with advanced solid tumors, including pancreatic cancer, ovarian cancer, and colorectal cancer, of which clinical outcome of standard of care remains poor.

COTA, Inc. Announces Participation in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program and DIA 2020 Virtual Global Annual Meeting

On May 29, 2020 COTA, Inc., a healthcare technology company that uses real-world data (RWD) to bring clarity to cancer care, is pleased to announce its involvement and participation in two industry leading conferences – the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program taking place May 29-31 and the DIA 2020 Virtual Global Annual Meeting to be held June 14-18 (Press release, COTA, MAY 29, 2020, View Source [SID1234558769]). Collectively, the involvement at these two premier events further underscores the importance of RWD’s role in clinical research and oncology care delivery.

"As real-world data continues to play an increasing role in clinical research with expanding regulatory applications, COTA is proud to be a leader in the space, and share our expertise and findings at two of the industry’s most important meetings," said Mike Doyle, President and CEO of COTA. "Not only are we working to provide clinically relevant insights that might otherwise remain hidden, but we are doing so by collaborating with industry experts, including Friends Of Cancer Research. This work is more important than ever during these unprecedented times, and we look forward to sharing our findings with conference attendees."

ASCO 2020 Areas of Study and Abstracts

The company is proud to announce that five abstracts have been accepted at ASCO (Free ASCO Whitepaper)’s 2020 annual meeting. The key areas of study include the following:

Characterization of African-American patients with multiple myeloma including time to 1st line therapy and 1st stem cell transplant.
Two abstracts as part of the Friends of Cancer Research RWE collaboration in oncology (Pilot 2.0)
Heterogeneity in the timing of IO uptake among patients with advanced non-small cell lung cancer
An analysis of patients with advanced non-small cell lung cancer to highlight the ability of RWD to generate evidence on patients that are routinely excluded from clinical trials.
Molecular markers of an NCCN-IPI prognostic model and its predictive power in a RWD cohort of patients with diffuse large b-cell lymphoma.
A literature review on techniques for the assessment of real-world progression and response to treatment in patients with multiple myeloma.
COTA has partnered with leading organizations, life science companies, hospitals, and cancer centers to produce these important findings. Links to the full abstracts and additional author information can be found below:

1. Incorporating molecular markers in standard prognostic models for DLBCL patients using real-world data.

2. Disparities in clinical characteristics and treatment of multiple myeloma in African American patients.

3. Trends in immunotherapy use in patients with advanced non-small cell lung cancer (aNSCLC) patients: Analysis of real-world data.

4. Overall survival (OS) in advanced non-small cell lung cancer (aNSCLC) patients treated with frontline chemotherapy or immunotherapy by comorbidity: A real-world data (RWD) collaboration.

5. Assessing real-world clinical response in patients with multiple myeloma (MM): A survey of the literature.

Industry Thought Leaders to Share Expertise at DIA 2020

In addition to its involvement in ASCO (Free ASCO Whitepaper)20, the Company will also be participating in DIA 2020, leading panel discussions with industry experts and thought leaders.

#301 SL: Combining Multiple Real World Data Sources to Maximize Value, will be held Wednesday, June 17, 2020 at 8:00 am. The discussion, led by COTA’s Chief Medical Officer, C.K. Wang, M.D., will discuss the approach and complexities to working with different real world datasets.
Panelists include Kim Van Naarden Braun, Associate Director, Translational Epidemiology, Informatics and Predictive Science, Bristol-Myers Squibb Company; Jennifer Christian, Vice President, Clinical Evidence and Epidemiology, IQVIA; and Jeremy Rassen, President and Chief Science Officer, Aetion.
#509 OD: ON DEMAND – Faster, Better, Cheaper: The Changing Role of Real World Data in Drug Development, will be available on demand for conference attendees. The session will explore how clinical trials will evolve in the era of big data from key regulatory leaders and real-world data experts. The discussion will be moderated by COTA’s Vice President of Life Sciences, Viraj Narayanan, MBA.
Panelists include Sean Khozin, Global Head of Data Strategy, Janssen Research & Development, LLC; Kimberly Wilson, Senior Director, Translational Epidemiology, Bristol-Myers Squibb Company; and Christopher Boone, Vice President, Global Head, Health Economics and Outcomes Research, Abbvie.
"As the value of real-world data becomes more accepted and its use more widely adopted, we are looking forward to speaking with industry leaders with invaluable insights on the topic," said CK Wang, M.D., COTA’s Chief Medical Officer. "With expertise spanning from a past Associate Director of the FDA, to an epidemiologist with over 20 years of healthcare research experience, as well as a pharmacoepidemiologist with 25 years of academic and industry experience, these will be fruitful discussions that can help push the industry forward as it expands its use of RWD."

Tolero Pharmaceuticals Presents Findings from First Clinical Studies Evaluating Investigational Agents TP-1287 and TP-3654 in Patients with Advanced Solid Tumors at ASCO Virtual Annual Meeting 2020

On May 29, 2020 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported data from the first clinical studies evaluating the oral investigational agents TP-1287, a cyclin-dependent kinase 9 (CDK9) inhibitor, and TP-3654, a PIM kinase inhibitor, in patients with advanced solid tumors (Press release, Tolero Pharmaceuticals, MAY 29, 2020, View Source [SID1234558768]). These results were presented in poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting, being held May 29-31, 2020.

Preliminary findings from a Phase 1, first-in-human, dose escalation study of TP-1287 showed clinical activity and a tolerable safety profile as a monotherapy in patients with heavily pretreated, relapsed and refractory solid tumors. In the study, 44% (n=12 of 27) of evaluable patients remained on treatment for more than four cycles. Additionally, 48% (n=13 of 27) of evaluable patients experienced a best response of stable disease, and one patient experienced a partial response. TP-1287 administered at a dose of 8 mg twice daily showed proof of mechanism by reducing levels of phosphorylated RNA polymerase II, a downstream target of CDK9.1

The most frequently observed Grade 3 adverse events in this study included diarrhea, anemia and pain. Pending the results from the dose escalation portion of the Phase 1 trial, the study will advance into a Phase 2 expansion in patients with metastatic castrate-resistant prostate cancer to evaluate clinical activity in this setting.1

Initial findings from a separate Phase 1, first-in-human, dose escalation study of TP-3654 presented at ASCO (Free ASCO Whitepaper) showed clinical activity and tolerability as a monotherapy in patients with heavily pretreated, relapsed and resistant solid tumors. Data from the study indicated that one-third of response-evaluable patients (33%, n=3 of 9) experienced stable disease for more than 16 weeks. Additionally, two-thirds of response-evaluable patients (67%, n=6 of 9) experienced a best response of stable disease. This study also found that patients administered TP-3654 had a reduction of BAD phosphorylation, a pro-survival downstream effector of PIM kinase activation. Further downstream biomarker data evaluating the impact of TP-3654 on the PIM kinase pathway are pending analyses.2

TP-3654 was tolerated up to doses of 1440 mg once daily with no dose-limiting toxicities observed. The dose escalation portion of the study is continuing with a twice daily dosing schedule to determine the maximum tolerated dose and recommended dose for a Phase 2 study.2

"We are pleased to share these clinical data on TP-1287 and TP-3654 at ASCO (Free ASCO Whitepaper), to support proof of mechanism for each investigational compound. These initial findings are representative of the continued advancement of our investigational pipeline of innovative cancer therapeutics," said David J. Bearss, Ph.D., Chief Executive Officer, Tolero Pharmaceuticals, and Chief Scientific Officer and Global Head of Research, Global Oncology. "We are continuing to progress these clinical programs as we build our understanding of the potential of TP-1287 and TP-3654 in various tumor types."

Below are the details for the presentations:

Abstract Title

Details

Author

A Phase I, First-in-human, Open-label, Dose escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 1287 Administered Daily to Patients with Advanced Solid Tumors

Abstract# 3611

May 29, 2020

8 a.m. ET

Poster Presentation

Ben George, M.D., Medical College of Wisconsin

A Phase I, First-in-Human, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 Administered Daily for 28 Days to Patients with Advanced Solid Tumors

Abstract# 3586

May 29, 2020

8 a.m. ET

Poster Presentation

Ignacio Garrido-Laguna, M.D., Huntsman Cancer Institute

About TP-1287

TP-1287 is an investigational oral cyclin-dependent kinase 9 (CDK9) inhibitor under evaluation in a Phase 1 study in patients with advanced solid tumors (NCT03604783). TP-1287 has shown favorable oral bioavailability in preclinical models.

About TP-3654

TP-3654 is an investigational second-generation selective PIM kinase inhibitor under evaluation in a Phase 1 study in patients with myelofibrosis (NCT04176198), led by Boston Biomedical, Inc., as well as a Phase 1 study in patients with advanced solid tumors (NCT03715504), led by Tolero Pharmaceuticals, Inc.

About CDK9 Inhibition and MCL-1

MCL-1 is a member of the apoptosis-regulating BCL-2 family of proteins.3 In normal function, it is essential for early embryonic development and for the survival of multiple cell lineages, including lymphocytes and hematopoietic stem cells.4 MCL-1 inhibits apoptosis and sustains the survival of leukemic blasts, which may lead to relapse or resistance to treatment.3,5 The expression of MCL-1 in leukemic blasts is regulated by cyclin-dependent kinase 9 (CDK9).6,7 Because of the short half-life of MCL-1 (2-4 hours), the effects of targeting upstream pathways are expected to reduce MCL-1 levels rapidly.6 Inhibition of CDK9 has been shown to block MCL-1 transcription, resulting in the rapid downregulation of MCL-1 protein, thus restoring the normal apoptotic regulation.3

About PIM Kinase

PIM kinases are major effectors of JAK/STAT proliferative signaling downstream of multiple growth factors and cytokines.8 PIM is overexpressed in cancers and it may enhance the ability of fibroblasts to differentiate into myofibroblasts.8

Agendia Announces Data Presented at ASCO 2020 Demonstrating Importance of Further Classification of Breast Cancers to Enable Precise Prognosis and Treatment

On May 29, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that new data from ongoing clinical research on MammaPrint and BluePrint was debuted at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (ASCO) (Free ASCO Whitepaper) (Press release, Agendia, MAY 29, 2020, View Source [SID1234558767]). A total of five posters were presented on Agendia’s genomic profiling assays.

The highlighted data below further illustrate the efficacy of Agendia’s MammaPrint and BluePrint genomic testing to consistently stratify breast cancers, allowing for a highly personalized regimen throughout a patient’s treatment journey. The latest findings from Agendia deliver immediate, actionable information for doctors and patients early in the diagnosis and treatment planning process and build on research that will impact breast cancer treatment and outcomes in the future.

One scientific presentation, entitled "Adding precision to 2018 ASCO (Free ASCO Whitepaper)/CAP HER2 testing guidelines in breast cancer with genomic profiling," evaluated the concordance between human epidermal growth factor receptor 2 (HER2) status as put forth by the 2018 ASCO (Free ASCO Whitepaper)/CAP guidelines and Agendia’s BluePrint genomic testing. In this real-world diagnostic data set, the 2018 guideline recommendations led to fewer HER2 equivocal tumors overall, confirming the positive impact of the revisions. Of note, BluePrint reclassified 69 percent of HER2-positive tumors and all HER2 equivocal tumors to non-HER2 molecular subtypes, indicating that these tumors may have suboptimal responses to HER2-directed therapy. This study found that molecular classification by BluePrint adds further precision in stratifying HER2-positive patients, offering the potential to predict responsiveness to HER2-targeted therapies.

"In this study, nearly 70 percent of HER2-positive diagnoses were reclassified to non-HER2, based on molecular subtyping. This is interesting and may have the potential at some point to affect treatment decisions and patient outcomes," said Adam Brufsky, MD, PhD, and Professor of Medicine at the University of Pittsburgh School of Medicine. "Data continue to show the value of MammaPrint and BluePrint as diagnostic tools that allow physicians to make more informed decisions to address their patients’ disease."

Also at ASCO (Free ASCO Whitepaper), Agendia shared updates on the ongoing FLEX trial, the massive real-world clinical data set designed to drive the medical community forward in its approach to precision medicine. In addition to a designated FLEX study poster – "The FLEX Real World Data Platform Explores New Gene Expression Profiles and Investigator-Initiated Protocols in Early Stage Breast Cancer" – that gave general updates on the registry, Agendia also highlighted FLEX and forward-looking studies, one of which has immediate implications for how a patient’s treatment may change based on comprehensive information uncovered by BluePrint.

The FLEX scientific presentation, entitled, "TNBC subtype and clinical estrogen receptor status of genomically basal breast tumors in Caucasian, African American, and Latin American patients," evaluated the distribution of triple-negative breast cancer (TNBC) subtypes in genomically Basal-Type cancers from self-reported patient ethnicities (Caucasian, African American, and Latin American). The data show that Basal-Type tumors are heterogeneous and include all defined TNBC subtypes, independent of ethnicity.

In addition, the study evaluated the association of IHC-determined estrogen receptor status and Basal-Type tumors of each ethnicity. Analyses demonstrated that BluePrint reclassified a subset of estrogen receptor positive (ER+) tumors to molecular Basal-Type and that ER status was not significantly associated with a specific TNBC subtype or ethnicity. This highlights the clinical need to trace basal biology in ER+ patients to refine treatment for basal-like tumors.

"The reclassification of a subset of ER+ tumors identifies an urgent and actionable situation," said Cathy Graham, MD, Assistant Professor of Surgery in the Division of Surgical Oncology at Emory University School of Medicine and Director, Breast Surgery at Emory St. Joseph’s Hospital. "From a clinical perspective, when these patients are first diagnosed, they appear to have luminal breast cancer. But, when you are able to look at the underlying mechanism with comprehensive genomic testing, a large subset of these breast cancers is reclassified to Basal-Type, which is high risk. This knowledge allows us to execute a more personalized and precise treatment approach immediately."

Two other forward-looking studies reinforce the future utility of better stratifying patients, and Agendia’s ability to provide a more sophisticated platform for discovery in gene signature research.

In the first, entitled, "High Risk breast cancer genes at 8q22-24 and their role in over 5,000 patients evaluated with the MammaPrint risk of recurrence assay," FLEX researchers looked at the 8q22-24 chromosomal region, known to be associated with breast cancer. The study results provided further evidence that aberrations in this region are associated with higher-risk disease. Within the MammaPrint signature, the genes CCNE2, MTDH, and TSPYL5 have similar expression patterns and when overexpressed, represent a unique subgroup of high-risk tumors. These findings and further research on the 8q22-24 region may help to better stratify high-risk patients through ongoing clinical trials evaluating response and resistance to targeted therapies.
The second, entitled, "12-chemokine gene expression score in breast cancer patients treated with neoadjuvant chemotherapy," builds on existing research related to gene expression as a predictive biomarker for immune responses in breast cancer patients. The study found that chemokine gene expression, which indicates the presence of immune cells, was associated with pathologic complete response (pCR), MammaPrint High Risk index, and BluePrint subtypes. This research suggests that chemokine score may be further stratified by using MammaPrint and BluePrint in order to identify patients who may be more likely to benefit from neoadjuvant chemotherapy. This work also suggests that future studies may evaluate the potential utility for chemokine score and MammaPrint in predicting responses to immunotherapy in breast cancer patients.
"The research we are showcasing at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting underscores our commitment to patients and physicians," said William Audeh, MD, Chief Medical Officer at Agendia. "With our growing arsenal of data collected through prospective clinical trials such as FLEX, I-SPY2 and MINDACT, we are able to help patients now while information-gathering for future breast cancer treatment strategy."

Agendia is proud to present these findings at the ASCO (Free ASCO Whitepaper) 2020 Annual Meeting, which underscore the company’s commitment to innovation and discovery through extraordinary, patient-focused research.

Amgen Presents New AMG 510 Clinical Data Across Multiple Solid Tumors During ASCO20 Virtual Scientific Program

On May 29, 2020 Amgen (NASDAQ:AMGN) reported new data from the CodeBreaK 100 clinical development program evaluating investigational AMG 510 (proposed INN sotorasib) in heavily pretreated patients with a range of KRAS G12C-mutant solid tumors (Press release, Amgen, MAY 29, 2020, View Source [SID1234558766]). Updated Phase 1 data from patients with advanced colorectal cancer (CRC) and other selected solid tumors continued to demonstrate disease control activity, safety and tolerability. These data are being presented during the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, May 29 – 31, 2020.

"Targeting KRAS has been a 40-year quest leaving patients with limited treatment options. In just under two years in the clinic, we have seen encouraging early efficacy and safety data across a number of solid tumors," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "New Phase 1 data at ASCO (Free ASCO Whitepaper) show that, in some patients with advanced colorectal cancer, sotorasib monotherapy provided prolonged disease control. A Phase 2 monotherapy study in advanced colorectal cancer has fully enrolled and will provide further insights into the potential utility of sotorasib in this disease."

Sotorasib Activity in Patients With Advanced Colorectal Cancer
CRC is the second leading cause of cancer deaths worldwide.1 It is the third most commonly diagnosed cancer globally and incidence is expected to grow by more than 20% over the next decade.2 For patients with previously treated metastatic CRC receiving standard therapies, unmet need remains high, with median progression-free survival (PFS) of about 2 months and response rates of less than 2%.3,4

This Phase 1 dose escalation study evaluated 42 heavily pretreated patients with advanced KRAS G12C-mutant CRC (data cut-off of Jan. 2020). All patients received prior systemic therapies (median of three prior lines), with 69% having received three or more prior lines of therapy. Twenty-two (52.4%) and eight (19.0%) patients remained on treatment for more than three and six months, respectively.

In the 960 mg once-daily target dose cohort, the objective response rate (ORR) was 12% (3/25) and the disease control rate (DCR) was 80% (20/25). Median PFS was 4.2 months and overall survival (OS) had not been reached after a median follow-up of almost 8 months. Tumor shrinkage was observed in 11 of 23 patients with available post-baseline tumor data.

Across all dose levels, the majority of patients achieved disease control, with an ORR of 7.1% and a DCR of 76.2%. Disease stability was maintained for a median of 4.2 months. Median PFS was 4.0 months and median OS was 10.1 months. Tumor shrinkage was observed in 18 of 39 patients with available post-baseline tumor data across all doses.

"There is currently a tremendous treatment gap for patients with advanced KRAS G12C-mutant colorectal cancer," said Marwan G. Fakih, M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope, Duarte, California. "These latest sotorasib data continue to show encouraging antitumor activity and tolerability in a patient population that has few treatment options."

Disease progression was the most common reason for treatment discontinuation. The majority of treatment-related adverse events (TRAEs) were Grade 1 and 2. Only two TRAEs were Grade 3 (diarrhea and anemia). There were no Grade 4 or higher TRAEs.

Sotorasib Activity in Patients With Advanced Solid Tumors Other Than NSCLC or CRC
Data were evaluated for 25 heavily pretreated patients with advanced KRAS G12C-mutant solid tumors other than CRC or NSCLC. These patients had received a median three prior lines of therapy with a median follow-up of 4.3 months.

These data demonstrated early evidence of a consistent safety profile and anticancer activity across a range of advanced KRAS G12C-mutant solid tumors, including pancreatic, appendiceal and endometrial cancer. Partial responses were confirmed in three patients with appendiceal, melanoma and endometrial cancer, respectively. Six of eight evaluable patients with pancreatic cancer achieved stable disease, and three had approximately a 30% reduction in tumor burden from baseline. Tumor shrinkage was observed in 13 of 19 evaluable patients with available post-baseline tumor data across all tumor types.

A complete listing of Amgen posters is available on the ASCO (Free ASCO Whitepaper) website at www.asco.org.

About KRAS
The subject of almost four decades of research, the RAS gene family contains the most frequently mutated oncogenes in human cancers.5,6 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.5 A specific mutation known as KRAS G12C is found in approximately 13% of non-small cell lung cancers, 3% to 5% of colorectal cancers and 1% to 2% of numerous other solid tumors.7-9 The KRASG12C protein has been considered "undruggable" due to a lack of traditional small molecule binding pockets on the protein. Amgen is exploring the potential of KRASG12C inhibition across a broad variety of solid tumor types.

About CodeBreaK
The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C-mutant solid tumors and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 1 study is safety, and key secondary endpoints include objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.

Amgen’s single-arm Phase 2 trials in both non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) (also part of CodeBreaK 100) are now fully enrolled. The potentially registrational Phase 2 trial in NSCLC is on track for data readout in 2020. The Phase 2 CRC trial is expected to have a data readout in early 2021.

Amgen is currently enrolling six Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101). In addition, a randomized global Phase 3 confirmatory study in NSCLC (CodeBreaK 200) has been initiated. Additional information about CodeBreaK clinical trials can be found at View Source