News Digest for June 2019

Posted on: 2019-07-12 10:36:54

June 2, 2019

The treatment of EGFR-mutant non–small cell lung cancer (NSCLC) has experienced significant improvements with the development of tyrosine kinase inhibitors (TKIs), but resistance mechanisms that promote disease recurrence have tampered the runaway success of these revolutionary agents, said Katerina A. Politi, PhD, Yale (more)  One novel antibody that is showing early signs of efficacy in this arena is JNJ-61186372, a bispecific antibody that targets EGFR and cMET receptors. Following Politi’s presentation, Eric B. Haura, MD, reported the latest findings from an ongoing first-in-human phase I study (NCT02609776).

******

The anti–vascular endothelial growth factor (anti-VEGF) agent bevacizumab (Avastin) carries indications for lung cancer, colorectal cancer, breast cancer, and glioblastoma, and has been the target of multiple hopeful biosimilar challengers. Alongside this week’s 2019 annual meeting of the American Society of Clinical Oncology (ASCO), 3 developers reported on their progress with developing biosimilars of this anticancer agent.  (more)

Daiichi Sankyo Presents Preliminary Phase 1 Data for HER3 Targeting ADC U3-1402 in Patients with EGFR Mutated Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting (more)

Women with advanced non-small cell lung cancer (NSCLC) may benefit more from the combination of chemotherapy plus PD-1/PD-L1 inhibitors compared with men, according to the results of 2 meta-analyses (more)

******

Mersana Therapeutics, Inc. (MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today presented new interim efficacy and safety data from its ongoing Phase 1 dose-escalation study evaluating XMT-1536, its first-in-class ADC candidate targeting NaPi2b, in patients with ovarian cancer, non-small cell lung (NSCLC) adenocarcinoma and other tumor types.  (more)

******

Pembrolizumab Increases Historic Survival Rate for Certain People with Advanced Non-Small Cell Lung Cancer (more and more)

Neoadjuvant Atezolizumab Yields Encouraging Responses in Patients With Resectable NSCLC (more)

ASCO: Forget lung cancer history. Merck's Keytruda shatters the stats on long-term survival (more)

Initial results of NRG-LU001 indicate that, although the diabetes agent metformin was well-tolerated by patients, the agent has not clearly improved progression-free survival (PFS) or overall survival (OS) for trial participants with locally advanced non-small cell lung cancer (NSCLC). These results are based on local center reported outcomes. Trial participants will continue to be followed for changes in their status.  (more)

June 4, 2019

BerGenBio a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, today presents updated data from its Phase II clinical trial (BGBC008, NCT03184571) with bemcentinib and Merck's anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced non-small cell lung cancer (NSCLC) (more)

Daiichi Sankyo Presents Preliminary Phase 1 Data for TROP2 Targeting ADC DS-1062 in Patients with Non-Small Cell Lung Cancer (more)

New Data from GEOMETRY mono-1 Study Show Clinically Meaningful Results in Patients with Non-Small Cell Lung Cancer with MET exon-14 Skipping Mutation Treated with Capmatinib (more)

In a study led by UCLA investigators, treatment with the immunotherapy drug pembrolizumab helped more than 15% of people with advanced non-small cell lung cancer live for at least five years - and 25% of patients whose tumor cells had a specific protein lived at least that long. (more and more)

SOTIO, a biotechnology company owned by the PPF Group, presented new statistically and clinically significant results from its Phase I/II clinical trial evaluating DCVAC/LuCa, an active cellular immunotherapy product, in patients with stage IV non-small cell lung cancer. The final analysis of the data confirmed the promising clinical efficacy of DCVAC/LuCa. (more)

Bevacizumab Could Help Patients With NSCLC Who Cannot Receive PD-1 Inhibitors (more)

Adjuvant Pemetrexed Plus Cisplatin: A Safer Option for Non-Squamous NSCLC? (more)

Does Adding Metformin to Chemoradiotherapy Improve NSCLC Survival? (more)

June 5, 2019

Osimertinib commentary from Dr. Sai-Hong Ignatius Ou, MD, PhD, University of California, Irvine School of Medicine.

https://www.onclive.com/inside-oncology/post-elcc-perspectives/osimertinib-in-advanced-egfr-t790m-mutant-nsclc

https://www.onclive.com/inside-oncology/post-elcc-perspectives/sequencing-with-osimertinib-in-egfr-mutated-nsclc

https://www.onclive.com/inside-oncology/post-elcc-perspectives/resistance-to-osimertinib-in-egfr-mutated-nsclc

June 6, 2019

EGFR-A763_Y764insFQEA: A unique exon 20 insertion mutation that displays sensitivity to all classes of approved lung cancer EGFR tyrosine kinase inhibitors. (more)

Real-world treatment outcome of advanced Chinese NSCLC EGFR exon 20 insertion patients.  (more)

Antitumor activity of TAK-788 in NSCLC with EGFR exon 20 insertions.  (more)

Osimertinib (Osi) plus necitumumab (Neci) in EGFR-mutant NSCLC: An ETCTN California cancer consortium phase I study.  (more)

******

RELAY: Ramucirumab Shows Benefit in Metastatic Lung Cancer (more)

Pembrolizumab Improves Survival in Advanced Non-Small Cell Lung Cancer (more)

Miriam Knoll, MD, and Richard J. White, DO, on Non–Small Cell Lung Cancer: Predicting Radiotherapy/Immunotherapy Treatment Outcomes (more)

Asuragen NGS System Streamlines Detection of NSCLC-associated DNA Mutations, Gene Fusions, and RNA Expression Targets in Single Workflow (more)

#ASCO19: MET inhibitors from Incyte/Novartis and Germany's Merck face off for rare subset of NSCLC patients (more)

Capmatinib, a highly selective a potent MET inhibitor, showed promising signs of clinical efficacy in a rare subtype of patients with non-small cell lung cancer (NSCLC) identified by a MET exon 14 (METex14) skipping mutation, MD Magazine reported. (more)

Immune checkpoint inhibitors are associated with similar survival outcomes among patients with advanced non–small-cell lung cancer (NSCLC), regardless of a patient’s history of autoimmune disorders, according to a retrospective study. Such patients are typically excluded from clinical trials. Overall frequency of adverse events was similar between the two groups, but a secondary analysis revealed higher rates of some adverse events in patients with active autoimmune disease, suggesting caution in this group.  (more)

Two targeted therapies in development have demonstrated encouraging activity as potential treatments targeting hard-to-target driver alterations in lung cancer. During the 2019 ASCO Annual Meeting, Christine M. Lovly, MD, PhD, reviewed the early promising findings for TAK-788 for patients with non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertions and for BLU-667 for patients with RET rearrangements.  (more)

******

Nearly double the number of patients with advanced non-small cell lung cancer (aNSCLC) would be eligibile for clinical trial enrollment if a broader set of eligibility criteria proposed by the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research was implemented, according to data presented at the 2019 ASCO Annual Meeting. (more)

When the targeted agents ramucirumab (Cyramza) and erlotinib (Tarceva) were combined, progression was delayed by 7 months in patients with newly diagnosed EGFR-positive non–small cell lung cancer (NSCLC) compared to erlotinib alone, according to findings from the phase III RELAY trial.  (more)

The investigational KRASG12C inhibitor AMG 510 achieved a 50% response rate in patients with KRASG12C-positive advanced non–small cell lung cancer (NSCLC), according to results from a phase I study presented at the 2019 ASCO Annual Meeting. (more)

June 7, 2019

Preliminary findings for a first-in-human study of JNJ-372 – a bispecific IgG antibody targeting both the EGFR and cMET receptors – have been reported at the 2019 ASCO Annual Meeting in Chicago, Illinois, USA.  Presenting author Eric Haura, from Moffitt Cancer Center in Tampa, Florida, USA, reported that the agent was tested in 142 patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations after preclinical analysis in multiple models of EGFR- and cMet-mediated tyrosine kinase inhibitor (TKI) resistance.  The data from these early studies was “consistent” with the proposed antitumor mechanisms of signalling inhibition, receptor degradation, and antibody-dependent cellular cytotoxicity, he explained.  (more)

June 12, 2019

Genomic Testing and Targeted Therapies May be Underused in Community Practice, Study Shows (more)

Dr. Kris on Predicting Benefit With Osimertinib in EGFR+ NSCLC (more)

Dr. Garassino on Erlotinib/Ramucirumab Versus Osimertinib in EGFR+ NSCLC (more)

Dr. Clarke on Combination Approaches Beyond Progression on Osimertinib in Lung Cancer (more)

Targeted Drug MEK Inhibitors for NSCLC Market 2019-2024 growing vigorously with top key players like Novartis (more)

June 13, 2019

Genomic Testing and Targeted Therapies May be Underused in Community Practice, Study Shows (more)

Dr. Kris on Predicting Benefit With Osimertinib in EGFR+ NSCLC (more)

Dr. Garassino on Erlotinib/Ramucirumab Versus Osimertinib in EGFR+ NSCLC (more)

Dr. Clarke on Combination Approaches Beyond Progression on Osimertinib in Lung Cancer (more)

Targeted Drug MEK Inhibitors for NSCLC Market 2019-2024 growing vigorously with top key players like Novartis (more)

June 14, 2019

Reports of the Demise of Chemotherapy Have Been Greatly Exaggerated (more)

Immutep Limited, a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, announces that 17 patients have been enrolled into the first cohort of the first line non-small cell lung cancer (NSCLC) arm (Part A) of the Phase II TACTI-002 clinical trial. This completes patient recruitment of the initial cohort of the study Part A. TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada).  (more)

The Association of Community Cancer Centers (ACCC) is collaborating with AstraZeneca and other partners to launch a national initiative to support quality care improvement for stage III and IV non-small cell lung cancer (NSCLC). (more)

June 15, 2019

TAK-788 shows activity against NSCLC with EGFR exon 20 insertions (more)

We morein report a case of squamous cell transformation combined with the epidermal growth factor receptor (EGFR) mutation T790M associated with acquired resistance to EGFR tyrosine kinase inhibitors (EGFR?TKIs) in a 73?year?old male patient diagnosed with stage IVA lung adenocarcinoma. (more)

*******

Impact of MET inhibitors on survival among patients with non-small cell lung cancer harboring MET exon 14 mutations: A retrospective analysis (more)

RELAY Phase 3: Efficacy of the Addition of Ramucirumab to Erlotinib in EGFR-Mutant Metastatic NSCLC (more)

Tecentriq Combo Prolongs Life of Lung Cancer Patients with Liver Metastases, Phase 3 Study Shows (more)

Despite the sequential efficacy of some of the FDA-approved EGFR TKIs, frontline osimertinib (Tagrisso) confers the greatest progression-free survival (PFS) advantage for patients with EGFR-positive non–small cell lung cancer (NSCLC), explained Jeffrey M. Clarke, MD. (more)

June 20, 2019

Quest Continues to Turn NSCLC Into Chronic Disease (more)

Immunotherapy Side Effects Could Mean Treatment Is Working in Non-Small Cell Lung Cancer (more)

‘Yuhan’s Lazertinib promising as 1st-line therapy for NSCLC’ (more)

Interpreting the Role of the Ramucirumab Plus Erlotinib Combination in EGFR+ NSCLC (more)

Patients with non-small lung cancer (NSCLC) who experience skin toxicity are more likely to respond to checkpoint inhibitor immunotherapy, according to study findings in JAMA Oncology. (more)

Adding bevacizumab improves overall survival in NSCLC (more)

Analyzing Best Practices for Targeting EGFR Resistance Mutations in EGFR+ NSCLC (more)

June 21, 2019

Efficacy of Maintenance Therapy After Induction Therapy in Patients With Nonsquamous NSCLC and Wild-Type EGFR (more)

Dr. Langer on the Current State of Immunotherapy in Advanced NSCLC (more)

Continuation of “Atalante 1” Phase 3 Clinical Trial of Tedopi® in NSCLC Patients Post Checkpoint Inhibitor Failure Following IDMC Recommendation (more)

Dr. Sands on the Rationale to Explore DS-1062 in Advanced NSCLC (more)

RELAY: Ramucirumab, erlotinib combination improves PFS in EGFR-mutated metastatic NSCLC (more)

June 22, 2019

Nivolumab Plus Ipilimumab Combination Therapy for the First-line Treatment of NSCLC: Evidence to Date (more)

Concurrent TP53 mutations predict poor outcomes of EGFR-TKI treatments in Chinese patients with advanced NSCLC (more)

Dr. Antonia on Investigational Immunotherapy Combinations in Stage III NSCLC (more)

Bemcentinib-Keytruda Combo Provides Durable Response in Advanced NSCLC, Phase 2 Trial Shows (more)

June 26, 2019

Dr. Mark Kris:  The emergence of osimertinib (Tagrisso) in the EGFR-positive non–small cell lung cancer (NSCLC) treatment paradigm has led to unprecedented progression-free survival (PFS) in patients, said Mark G. Kris, MD. Now, researchers are channeling their efforts into optimizing patient selection for and outcomes with the targeted therapy.  (more)

WindMIL Therapeutics, a clinical-stage company developing marrow-infiltrating lymphocytes (MILs™) for cancer immunotherapy, announced today that it has been cleared by the U.S. Food and Drug Administration (FDA) to proceed with its Phase 2 study of MILs as a potential treatment for patients with non-small cell lung cancer (NSCLC) who have progressed on an anti-PD-1 containing regimen. The clearance was received following WindMIL’s submission of an investigational new drug (IND) application for this program. (more)

Dr. Daniel Gomez: Combined Modality Approach May Benefit Select Patients With Oligometastatic NSCLC (more)

June 27, 2019

Tedopi®, a combination of neoepitopes, is OSE Immunotherapeutics’s most advanced product, currently in Phase 3 clinical trial in patients with non-small cell lung cancer (NSCLC) post immune checkpoint inhibitor treatment failure (PD-1/PD-L1). On June 20, 2019, after reviewing global study data, the Independent Data Monitoring Committee (IDMC) for this trial saw no safety concerns and recommended the continuation of patient recruitment, without any modifications, thus supporting Tedopi®’ s development in a patient population with no currently approved therapeutic option, and with strong clinical need.  (more)

Mirati Therapeutics plans to raise more than $200 million this week in a public offering, funding that it plans to use to advance its lead cancer drug candidate, sitravatinib, into late-stage testing, and to continue developing its other targeted oncology programs.  Mirati’s sitravatinib is an experimental treatment for patients with non-small-cell lung cancer (NSCLC). The company is testing the drug in combination with checkpoint inhibitors, a type of cancer immunotherapy, to target a class of proteins called tyrosine kinases. The combination will be compared to chemotherapy. (more)

June 28, 2019

During a median follow-up period of 20.4 months, 10.3% of 748 patients with locally advanced NSCLC who were treated with thoracic radiotherapy developed at least one MACE (cardiac death, unstable angina, myocardial infarction, hospitalization for heart failure, and coronary revascularization) and 71.3% died. (more)

David Spigel, MD, chief scientific officer, Sarah Cannon Research Institute, director of the Lung cancer Research Program, and member of the Association of Community Cancer Centers (ACCC) explains to Targeted Oncology, the ways in which ACCC is improving the care landscape and outcomes for patients with advanced non–small cell lung cancer (NSCLC). (more)

Dr. Paik on Tepotinib in METex14-Mutated NSCLC (more)

June 29, 2019

Patients who received corticosteroids for palliative reasons drove an overall negative impact of steroids on immunotherapy for advanced non-small cell lung cancer (NSCLC), a retrospective analysis showed. (more and more)

Dr. Gutierrez on Biomarker-Directed Precision Oncology of Pembrolizumab-Based Combos in NSCLC (more)