In the top three news from Onco-this-Week, Richa Tewari highlights discontinuation of a randomized Phase II study in non-small cell lung cancer patients, top-line results from Phase IIa COMBAT/KEYNOTE-202 trial in pancreatic cancer and sNDA acceptance with priority review to Ibrutinib + Obinutuzumab in first line chronic lymphocytic leukemia patients. Our trivia section features a QnA on the different lines of cancer treatments and check out how the stage of tumor progression defines the line of treatment. Also featured is the news about Astra Zeneca’s and Merck’s Lynparza receiving a special status designation from FDA for treatment of pancreatic cancer. – Abhi Dey
- Discontinuation of randomized Ph II SHRLOC study in NSCLC patients. Merrimack Pharmaceuticals got another clinical setback with its HER3 inhibitor MM-121 (seribantumab) failing in a randomized Phase II trial in NSCLC patients. Already grappling with the failure of MM-141 (istiratumab) in pancreatic cancer earlier this year, Merimack’s shares further plummeted and the company definitely will be keeping its fingers crossed on the outcome of MM-121 in breast cancer trial (SHERBOC) and of MM-310, an EphA2R-targeting ADN in solid tumors. The development of MM-121 and fate of SHERBOC trial is going to be assessed soon.
- Top-line results from Ph IIa COMBAT/KEYNOTE-202 trial in pancreatic cancer. Though BioLineRx projects the top-line data as ‘encouraging’ in terms of 37% disease control rate, the investors and market analysts find the outcomes pretty disappointing since the combination of CXCR4 inhibitor BL-8040 and Pembrolizumab could secure just one PR out of these. The company announces a triple combination arm with added chemotherapy to start later this quarter with top-line data expected in H2 2019 as a salvage plan.
- sNDA acceptance and priority review to Ibrutinib + Obinutuzumab in 1L CLL patients. Based on positive results from the Ph III iLLUMINATE (PCYC-1130) trial where the combination met the primary endpoint of PFS improvement in May this year, it was pretty predictable to see Ibrutinib-Obintuzumab’s combination moving towards FDA approval. Ibrutinib has strongly consolidated position in CLL, as the only therapy with longest follow-up data – this approval will only strengthen its position in CLL and SLL treatment paradigm.
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DRUG APPROVALS
FDA approves Talazoparib in gBRCA+ HER2neg breast cancer based on EMBRACA results
#talazoparib was #FDAapproved this week for the treatment of BRCA+ advanced #breastcancer. By inhibiting PARP in cells with mutated BRCA, single-strand DNA breaks can’t be repaired & resulting DNA damage leads to cell death. #BreastCancerAwarenessMonth #medchem #drugdiscovery pic.twitter.com/bM8GcMY2nF
— ACS Division of Medicinal Chemistry (@AcsMedi) October 18, 2018
“Women with a hereditary BRCA mutation are typically diagnosed with breast cancer at a younger age than the overall breast cancer population and have limited treatment options when they develop advanced disease,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “Today’s filing acceptances are just the latest example of the success of Pfizer’s precision medicine approach to drug development, in this case targeting the faulty DNA damage repair process associated with BRCA mutations. We are now one step closer to offering a potential alternative to chemotherapy for these patients.”
SPECIAL STATUSES
Olaparib granted orphan drug designation in Pancreatic Cancer
BREAKING: Olaparib has been granted an orphan drug designation by the FDA for the treatment of patients with pancreatic cancer: https://t.co/Z7WRsLhSiJ #PancreaticCancer #CancerResearch pic.twitter.com/F5XrCIc9uR
— Targeted Oncology (@TargetedOnc) October 17, 2018
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer said: “Pancreatic cancer is an area of significant unmet medical need. This is especially true for patients with metastatic disease where the benefits of current treatment options are very limited.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, at MSD Research Laboratories, said: “Pancreatic cancer is a relatively less common, but life-threatening, form of cancer. The FDA granting Orphan Drug Designation is a positive step for patients with pancreatic cancer and continues to reinforce the importance of our collaboration in bringing Lynparza to more patients in need.”
REGULATORY NEWS
Tocagen Provides Update on European Regulatory Path for Toca 511 & Toca FC
Tocagen Provides Update on European Regulatory Path for Toca 511 & Toca FC https://t.co/D2Si0JvDK7
— Crwe World (@CrweWorld) October 2, 2018
“We are pleased the global Toca 5 trial has the potential to serve as the basis for a regulatory application in Europe, which we believe may expedite the advancement of Toca 511 & Toca FC as a treatment for patients with brain cancer. If the pivotal trial data are positive, our gene therapy would be the first medicine in over 20 years to show a treatment benefit in a randomized trial in patients with this disease,” said Marty Duvall, chief executive officer of Tocagen. “Our interactions with the European regulators under the PRIME pathway are conducted in the spirit of collaboration and urgency to bring forward a new treatment for brain cancer as quickly as possible.”
Japanese Approval Sought for Quizartinib in FLT3-ITD+ AML https://t.co/11yPJ9ey5z pic.twitter.com/dDTvb2171F
— Immuno-Oncology (@immuno_onc) October 18, 2018
“Quizartinib has been designed as a specific inhibitor of FLT3 with high affinity for FLT3-ITD, a driver mutation in AML that is linked to poor prognosis and is associated with aggressive disease that results in increased relapse rate and reduced overall survival for patients compared to those without this mutation,” said Kouichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. “We look forward to working closely with the Japan Health Authority on our application for quizartinib in order to bring this important potential new targeted treatment option to patients with relapsed/refractory FLT3-ITD AML in Japan.”
The @US_FDA has granted a priority review to @abbvie‘s combination therapy, ibrutinib/obinutuzumab, for the treatment of previously untreated adult patients with chronic lymphocytic #leukemia or small lymphocytic #lymphoma
READ: https://t.co/6d9SqoSCf3 pic.twitter.com/lv0usBXf3P
— Rare Disease Report (@RareDR) October 17, 2018
“Our robust clinical research program with IMBRUVICA continues to reinforce the evidence for its use as an efficacious treatment option in CLL and SLL, this time versus a National Comprehensive Cancer Network guidelines Category 1 treatment, which is the chemoimmunotherapy combination of chlorambucil plus obinutuzumab,”2 said Danelle James, M.D., M.A.S., Head of Clinical Science, Pharmacyclics LLC, an AbbVie company. “Further, for the first time in CLL, results from iLLUMINATE have shown the potential benefits of using an IMBRUVICA-based, chemotherapy-free, anti-CD20 combination. Since its initial approval five years ago, IMBRUVICA has received nine FDA approvals across six different diseases, and we remain committed to advancing new research to understand its full potential in blood cancers like CLL and SLL, as well as other difficult-to-treat diseases with unmet medical needs.”
TRIAL RESULTS
“We are highly encouraged by these positive results with adjuvant Kadcyla treatment in people with HER2-positive early breast cancer who have residual disease after neoadjuvant therapy,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to discussions with regulatory authorities with the goal of bringing this new treatment option to patients as soon as possible.”
Roche Reports Kadcyla (trastuzumab emtansine) vs Herceptin (trastuzumab) Achieve 1EP in P-III KATHERINE study @Rochehttps://t.co/1kBMOS5tDU pic.twitter.com/wgqfpHr6GO
— PharmaShots (@Pharmashot) October 15, 2018
Axitinib and pembrolizumab- first time a survival signal has been seen with a VEGF TKI in the front line setting. pic.twitter.com/OyXpsLt0dr
— Uromigos (@Uromigos) October 18, 2018
“KEYTRUDA, in combination with the tyrosine kinase inhibitor Inlyta, resulted in significant and clinically meaningful improvements in overall survival, progression-free survival and objective response in this Phase 3 study. This marks the first time that combination treatment with an anti-PD-1 therapy has achieved the dual primary endpoints of overall survival and progression-free survival as first-line therapy in advanced renal cell carcinoma,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Fewer than 10 percent of those diagnosed with advanced renal cell carcinoma survive for five years, and hence there is significant need for improved therapies for this disease. We are very grateful to the investigators and patients for their involvement in this important study, the results of which will be filed with global regulatory authorities in the near future.”
“We are very disappointed by the outcome of this study, in particular for patients and families facing this difficult diagnosis,” said Sergio Santillana, M.D., M.Sc., Chief Medical Officer of Merrimack. “We deeply appreciate the support from all investigators, patients and their families who participated in this trial. We also want to recognize our team’s efforts and commitment to the development of MM-121 in non-small cell lung cancer over the past several years.”
$MACK (-30.2% pre) Merrimack Terminates Ph 2 SHERLOC Study of MM-121 for Non-Small Cell Lung Cancer Due to Futilityhttps://t.co/XwL2FHHFJU
— Open Outcrier (@OpenOutcrier) October 19, 2018
“Our ability to make a swift decision regarding these results is based on our development approach of testing our targeted therapies in biomarker-defined patient populations, which allows us to accelerate the timeframe needed to obtain clear data read-outs,” said Richard Peters, M.D., Ph.D., President and Chief Executive Officer of Merrimack. “The data provide a definitive signal that MM-121 does not improve clinical outcomes for patients with non-small cell lung cancer and, in line with this efficient development strategy, we plan to look closely at the data as we assess the continued development of MM-121 and evaluate our pipeline more broadly.”
TRIAL STATUSES
“Metastatic triple negative breast cancer represents an extreme unmet medical need, where pre-treated patients rarely achieve objective responses with PD-1/PD-L1 checkpoint treatments,” said Dr. Pamela Munster, Professor of Medicine and Program Leader of Experimental Therapeutics at University of California San Francisco (UCSF). “The marked synergy of TAVO and checkpoint inhibition shown in previous clinical observations strongly suggests that IL-12 may prime the tumor microenvironment for PD-1/PD-L1 checkpoint treatments. This represents a highly promising therapeutic approach for TNBC.”
OncoSec Initiates KEYNOTE-890, a Phase 2 Clinical Trial of TAVO in Combination with Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Late-Stage Triple Negative Breast Cancer, full details via https://t.co/QDgsuXlnrw
— OncoSec Medical (@OncoSec) October 15, 2018
“The initiation of KEYNOTE-890 is an important milestone for OncoSec as it marks a significant expansion of our clinical pipeline as well as our expanding relationship with Merck,” said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec. “Our goal is to enroll this study as quickly as possible and provide preliminary topline data in 2019. Currently, overall survival for metastatic TNBC is one to two years from diagnosis, with therapies resulting in short-lived responses and/or significant toxicity. New approaches are desperately needed, and based on prior and ongoing clinical research, we beleive that TAVO in combination with KEYTRUDA® has the potential to be effective in treating this disease. Given the severe unmet medical need, it is possible that TAVO for the treatment of TNBC could be granted Fast Track designation, Breakthrough Therapy designation, and be a candidate for accelerated approval.”
“The I-SPY TRIAL is designed to evaluate multiple emerging new agents simultaneously with the goal of getting effective and potentially less toxic treatments to patients much more quickly. We are excited to add SD-101 into I-SPY 2, and combine it with pembrolizumab with the goal of extending responses previously observed with pembrolizumab alone,” stated Dr. Laura J. Esserman, MD, MBA, Principal Investigator of I-SPY 2 and Director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center.
Phase Ib/II study of the combination of SD-101 and pembrolizumab
in patients with advanced melanoma who had progressive disease on
or after prior anti-PD-1 therapy. $DVAX #TLR9 #ESMO18 pic.twitter.com/W91mZuL9dR— Volker Schulz (@portefeuillefun) October 19, 2018
“We are excited SD-101 has been chosen to be included in the I-SPY 2 trial and see this as an excellent opportunity to potentially expand its use into the emerging field of neoadjuvant immunotherapy,” stated Eddie Gray, chief executive officer of Dynavax.
@CheckOrphan Positive Recommendation by Independent Data Monitoring Committee on the #Phase3 Clinical Trial of SGX301 for the Treatment of Cutaneous T-cell Lymphoma https://t.co/xXXkgYo9Me $SNGX #raredisease #defendyourhealth #clinicaltrial #ctcl
— Soligenix, Inc. (@Soligenix_Inc) October 18, 2018
“We are pleased to have received the DMC’s recommendation to continue enrolling to the adjusted target of 160 evaluable subjects in order to maintain our conservative power calculation,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We have invested a significant amount of the Company’s resources over the last three years into the CTCL development program and it is gratifying to have received this feedback from the DMC indicating sufficient potential efficacy to warrant enrolling additional subjects into the trial. With this new level of clarity from the DMC’s analysis of the interim Phase 3 study data and given our current enrollment status of approximately 120 subjects, we anticipate completing the study before the end of 2019 with topline results coming no later than the first quarter of 2020. Given our current cash resources, we anticipate that the available funds are sufficient to cover the additional study patients needed. We believe SGX301 has the potential to be a valuable therapy in the treatment of early stage CTCL, which is an orphan disease and area of unmet medical need.”
“The DMC’s recommendation is very encouraging and will allow us to aggressively pursue completing the trial, demonstrating SGX301’s potential to successfully treat the CTCL index lesions using a combination therapy (SGX301 and the proprietary fluorescent light panel) that minimizes the long-term risks of treatment-associated secondary cancers,” stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. “SGX301 truly has the potential to have a significant impact on the lives of CTCL patients. We would like to thank the DMC members for their assistance, as well as our esteemed medical advisory board and our dedicated clinical investigators for their ongoing efforts in the design and conduct of this important clinical trial.”
Five Prime starts dose exploration in early-stage study of FPA150 in solid tumors; shares up 4% https://t.co/wICU8xxi5C $FPRX
— Breaking News (@MarketCurrents) October 16, 2018
“We’re excited to be ahead of schedule in opening up our dose exploration basket cohort for FPA150, our first-in-class B7-H4 antibody, in patients whose tumors overexpress B7-H4,” said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. “B7-H4 is generating excitement in investigators because it’s expressed in tumor types that are currently not well served by immunotherapy, including breast and gynecologic cancers. We’re hopeful that a targeted therapy like FPA150 will provide clinical benefit in these patients who have limited treatment options.”
Patient dosing started in Alvocidib Ph Ib/II Zella 102 trial in MDS patients
Tolero Pharmaceuticals Announces First Patient Dosed with Investigational Agent Alvocidib in Phase 1b/2 Zella 102 Study in Patients with Myelodysplastic Syndromes (MDS) https://t.co/rutD5yy1JA
— iHandy.eu (@nerdgadgets_eu) October 16, 2018
“We are pleased to initiate this Phase 1b/2 clinical trial of alvocidib in myelodysplastic syndromes,” said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals, Inc. “We hypothesize that downregulation of MCL-1 via CDK9 inhibition following decitabine exposure may result in enhanced antileukemic activity. We believe that there are some patients with MDS that may have disease dependent on MCL-1. This milestone supports our commitment to understanding the potential of alvocidib in this patient population.”
Ph I trial of AXL Inhibitor DS-1205 + Gefitinib started in EGFR+ve TKI-treated mNSCLC patients
Daiichi Sankyo launches phase 1 trial of DS-1205 in EGFR-mutated NSCLC: For patients with metastatic EGFR-mutated NSCLC, targeted EGFR TKI therapies such as gefitinib, erlotinib, afatinib or osimertinib represent the first-line treatment of choice.… https://t.co/bjA2FYaDi8
— cafepharma (@cafepharma) October 20, 2018
“This first-in-human trial will build upon preclinical research to evaluate the potential of our AXL inhibitor, DS-1205, in combination with gefitinib in EGFR-mutated NSCLC that has progressed on TKI therapy,” said Eric Slosberg, PhD, Head, Oncology Translational Development, Oncology Research and Development, Daiichi Sankyo. “We are evaluating for the first time in a clinical setting whether inhibition of the AXL pathway with DS-1205 may help prevent, delay or overcome the onset of resistance to EGFR TKIs, as we continue to research and develop new targeted therapy approaches for patients with metastatic NSCLC.”
First prostate cancer patient included in Ph II study of Irofulven for personalized treatment
“The initiation of this Phase 2 study in prostate cancer patients is an important milestone in the development of Irofulven. This has been long under way but is as relevant as ever. Despite of the success of the drug class called PARP inhibitors and other new developments the reality is that unfortunately, most prostate cancer patients with metastatic disease will experience progression of their disease and we see a high potential for these patients to benefit from Irofulven”, says Peter Buhl Jensen, M.D., CEO of Oncology Venture.
OV – First prostate cancer patient included in Oncology Venture’s Phase 2 study of Irofulven for personalized treatment – Nasdaq: OV – First prostate cancer patient included in Oncology Venture’s Phase 2 study of Irofulven for personalized treatment… https://t.co/XPUvVfZ0U4 pic.twitter.com/cQaK9mZmh9
— Oncology Board (@mb_Oncology) October 18, 2018
Klaus Edvardsen, Senior Vice President, Head of Oncology, Global Medicines Development, said: “We are committed to following the science to improve survival for all patients with EGFR-mutation positive NSCLC at every stage of disease. The ORCHARD trial will increase our understanding of resistance mechanisms and explore potential new treatment options to address the next stage of disease after 1st-line Tagrisso.”
MET, EGFR C797S Linked With Acquired Resistance to Frontline Osimertinib in NSCLC https://t.co/PgBS1uoqpV #ESMO18 #lcsm
— Jason Broderick (@Jasoncology) October 20, 2018
Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial from Winship Cancer Institute of Emory University, Atlanta, US, said: “The FLAURA trial ushered in a new standard of care with osimertinib as 1st-line therapy for EGFRm NSCLC. Today’s results provide direction for continued research into new treatment options after progression on 1st-line osimertinib therapy by studying MET-amplification and EGFR C797S, among other resistance mechanisms.”
DIAGNOSTIC ASSAYS
FDA approves BRACAnalysis CDx® as companion diagnostic for Talazoparib
“We congratulate Pfizer on obtaining FDA approval of TALZENNA for certain patients living with metastatic breast cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test,” said Lloyd Sanders, president, Myriad Oncology. “We estimate there are more than 60,000 patients diagnosed with or who progress to metastatic breast cancer in the United States every year who qualify for a BRACAnalysis CDx test.”
. @US_FDA Approves @myriadgenetics‘ BRACAnalysis CDx for Use with @pfizer‘s Talzenna: https://t.co/9AMW3hfNWA pic.twitter.com/VVAxbQ51rg
— Clinical OMICs (@ClinicalOMICs) October 20, 2018
“Myriad’s BRACAnalysis CDx test was shown in the EMBRACA trial to accurately identify certain patients with a germline BRCA-mutation who may benefit from TALZENNA,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer of Myriad Genetics. “It is important for patients to know their BRACAnalysis CDx results so they can fully understand their treatment options.”
“We are pleased to apply the Signatera technology to the patient samples that we will be receiving in connection with this clinical trial in order to measure the levels of ctDNA across multiple personal mutations,” said Richard Gaynor, M.D., president of research and development at Neon Therapeutics. “We endeavor to employ novel tools in order to develop high-quality treatments for cancer patients and look forward to the information that we will receive from this collaboration.”
.@neon_tx to use @NateraGenetics’ #biomarker platform to follow response in NT-002 #clinicaltrial vs NSCLC
Signatera monitors circulating #tumor DNA in #LiquidBiopsyhttps://t.co/LREda26G3g#diagnostics #oncology #cancer @SternIR @TenBridge pic.twitter.com/JFaZSz1Nwt
— DDNews Online (@DDNewsOnline) October 19, 2018
RESULTS: ESMO 2018
“Patients with metastatic midgut NET and a high liver tumor load at diagnosis have a poorer prognosis than patients with few liver metastases[2],[3],” said Jonathan Strosberg, MD, Associate Professor, Section Head, Neuroendocrine Tumor Program at Moffitt Cancer Center, and Principle Investigator of the NETTER-1 study. “These new data provide hope for these patients and reinforce the potential benefit of Lutathera treatment in this population.”
#NovartisNews: New NETTER-1 data explores impact of increased tumor burden in the liver on results in patients with #neuroendocrine tumors.
— Novartis (@Novartis) October 19, 2018
“These results from the NETTER-1 study continue to show that Lutathera delivers strong efficacy in patients with a challenging disease burden,” said Samit Hirawat, MD, Head of Novartis Oncology Global Drug Development. “Demonstrating improved PFS and maintenance of QoL in patients with neuroendocrine tumors with poor prognosis due to a high liver tumor burden is a great example of our commitment to reimagining cancer.”
Clovis Oncology presents initial results from the ongoing Rucaparib TRITON program in mCRPC patients
“Rubraca has previously demonstrated antitumor activity in its approved indications for women with advanced ovarian cancer,” said Dr. Abida. “These new data show that Rubraca may also offer a new approach for the treatment of mCRPC associated with BRCA1 and BRCA2 alterations, with the potential to achieve a clinical response in patients with few remaining therapy options.”
Clovis Oncology Presents Initial Results from the Ongoing Rubraca® (rucaparib) TRITON Program in Metastatic Castration Resistant Prostate Cancer (mCRPC) at ESMO 2018 Congress https://t.co/NvI2iqDt2v pic.twitter.com/pDfvwoUFqL
— PharmaMKT (@PharmaMKTnet) October 19, 2018
“We are very encouraged by these initial findings from the TRITON2 study, which demonstrate the potential of Rubraca to treat men with advanced prostate cancer whose disease has progressed after receiving multiple prior lines of therapy,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “PARP inhibitors are now a validated therapeutic class in oncology in multiple tumor types, and these new data underscore the benefit that Rubraca may provide for men with advanced, BRCA-mutant castration-resistant prostate cancer. Having recently received Breakthrough Therapy designation based on these data, we are committed to the rapid development of Rubraca for men with this very difficult-to-treat disease.”
“Tumor tissue testing relies heavily on archival samples taken when a patient is newly diagnosed but may not capture all the alterations that emerge in patients with metastatic disease,” said Dr. Chowdhury. “The screening data demonstrate that there is a high concordance between alterations detected in the tissue and plasma assays. Due to the less invasive nature of obtaining cfDNA through plasma testing, this method may be more suitable for both physicians and patients and may also identify more patients eligible for clinical trials of Rubraca.”
“ALK+ NSCLC often spreads to the brain, so having options that can clearly demonstrate efficacy both in the brain and systemically is important for physicians and their patients,” said Sanjay Popat, PhD, FRCP, Medical Oncologist, Royal Marsden Hospital. “The ALTA-1L trial showed that treatment with brigatinib significantly delayed progression of disease in the brain compared to crizotinib, and we look forward to sharing the clinical evidence with the medical community at ESMO.”
Among patients with ALK-positive #NSCLC who have not previously received an ALK inhibitor, progression-free survival is significantly longer in those who receive treatment with #brigatinib vs #crizotinib. https://t.co/SXdGZPRlPD
— Pulmonology Advisor (@PulmAdvisor) October 20, 2018
“CNS disease presents a significant burden for patients with ALK+ NSCLC,” said David Kerstein, MD, Global Clinical Lead for Brigatinib and Lung Cancer Clinical Portfolio Strategy Lead, Takeda. “These additional intracranial efficacy results from the ALTA-1L trial build upon activity previously reported with ALUNBRIG in patients with brain metastases in the post-crizotinib setting and demonstrate Takeda’s dedication to research that aims to improve outcomes for those living with this serious disease.”
“These preliminary findings reveal the potential of capmatinib in MET exon-14 skipping mutated NSCLC patients. Compared to the previously treated patient groups, the primary advantage in terms of overall response rate reported in treatment-naive patients highlights the clinical relevance for an earlier diagnostic testing and prompt treatment of this challenging patient population,” said Juergen Wolf, MD, University Hospital Cologne.
ESMO18 Insights >>> Published by EGFR Resisters in Twitter: RT @ivybelkins: Capmatinib shows good promise for #lungcancer patients with MET exon 14 skipping mutations #lcsm #ESMO18 @myESMO https://t.… https://t.co/gZEb1heCLh #followthepatient #LucidQuest #ESMO18 pic.twitter.com/OQ3m0n7X0u
— Dr Timos Papagatsias (@_timos_) October 20, 2018
“Patients diagnosed with advanced MET mutated NSCLC represent an unmet medical need and often face a poor prognosis,” said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development. “We are encouraged by the GEOMETRY mono-1 results and the potential for capmatinib to help patients with this disease.”
BioLineRx Presents Top-Line Results from Ph IIa COMBAT/KEYNOTE-202 Study in Pancreatic Cancer
Prof. Manuel Hidalgo, MD, PhD, Professor of Medicine at Harvard Medical School, Chief of Hematology Oncology and Co-Director, Pancreatic Cancer Research Program, at Beth Israel Deaconess Hospital, and principal investigator of this study, said, “Metastatic pancreatic cancer remains an area of very high unmet medical need, as currently approved treatments are limited by poor response rates and survival. Despite recent advances in cancer treatment with immune checkpoint inhibitors in many tumor types, pancreatic cancer remains refractory to these treatment options. It is therefore encouraging to see that the combination of BL-8040 and KEYTRUDA shows promising clinical activity, a robust pharmacodynamic effect and a very good safety and tolerability profile. I look forward to the next phase of this study, in which chemotherapy will be added to the combination of BL-8040 and KEYTRUDA in an expansion cohort. I believe that the addition of chemotherapy may boost the clinical response rate, while hopefully maintaining the favorable safety and tolerability profile observed in this arm of this trial.”
BioLineRx Discloses Additional Data from Phase 2a COMBAT/KEYNOTE-202 Study in Pancreatic Cancer at ESMO 2018 Congress https://t.co/zI5xO0q4YH
— iHandy.eu (@nerdgadgets_eu) October 20, 2018
“We are extremely pleased with the top-line results from this ongoing study,” stated Philip Serlin, Chief Executive Officer of BioLineRx. “These data, which demonstrate that the combination of BL-8040 and KEYTRUDA is safe, with encouraging signs of clinical activity and proof of concept for the mechanism of action, support the combination’s potential to become an effective immunotherapy regimen for pancreatic cancer – a disease that has responded very poorly to available treatments, including immunotherapy. We look forward to expanding our collaboration with MSD and maximizing the potential of this combination through an additional study arm that will add chemotherapy to the regimen. We believe the addition of chemotherapy may be synergistic with the existing combination, as chemotherapy has been shown to reduce overall tumor burden while inducing immunogenic cell death, leading to activation and expansion of new tumor-reactive T-cells. Based on its demonstrated mechanism of action, we believe BL-8040 can facilitate the infiltration of these T-cells into the tumor core, alongside the restoration of T-cell activity within the tumor by KEYTRUDA. We look forward to commencing the triple combination arm of this important study by the end of this year, with results expected in the second half of 2019.”
LINES OF THERAPIES
Q: What are different lines of therapies used in oncology treatment?
A: The lines of therapies most commonly used in oncology are neo-adjuvant, adjuvant, induction, front-line (or 1L), second line (2L), maintenance, consolidation, etc.
Q: How is line of therapy usually defined in solid tumors?
A: Line of therapy is usually defined by stage (early stage vs. metastatic stage).
Q: What are the lines of therapies in early stage tumors?
A: In early stage, the lines of therapies given are neo-adjuvant and adjuvant. Neo-adjuvant therapy is given before surgery to shrink the tumor. Adjuvant treatment is given after the surgery to maintain the response obtained by surgery.
Q: What are the lines of therapies in metastatic stage tumors?
A: The newly diagnosed patients in metastatic settings are given front-line or 1L therapy. In case of a response obtained, the response is maintained with maintenance/consolidation therapy. Once the patients progress, they are given second line therapy and so on.
Q: How are lines of therapies different in treatment of hematological malignancies?
A: Since there are no localized tumors that can be resected, there are no neo-adjuvant or adjuvant therapies. The newly diagnosed patients are given frontline or induction treatment.
Q: What are the tumors with exceptions?
A: Though the above is followed in most solid tumors, the lines of therapies may differ in some indications. An example would be bladder cancer, where line of therapies are further defined by patient segments, non-muscle invasive bladder cancer (BCG-refractory, post-TURBT), muscle invasive bladder cancer (neo-adjuvant and adjuvant), and metastatic bladder cancer (1L, 2L etc.).
Reference: https://www.cancer.gov/publications/dictionaries/cancer-terms
About the Author:
Richa earned her PhD at the National Brain Research Centre, India. For her thesis, she worked on the dreaded Glioblastoma multiforme. That was her first in-depth exposure to academic research in cancer biology. After her PhD, she expanded her research experience by working in the field of immunology at UCLA, USA. After her return to India, Richa switched to a corporate setting but continued her engagement with the cancer field. She is currently loving her work, which affords her the opportunity to continue developing her knowledge in the biomedical field of cancer. Outside of work, she enjoys watching, identifying and photographing birds.
Editor and Blog Design:
Abhi graduated from the Molecular Biophysics Unit of IISc (Bangalore, India) in 2011. As a Biomedical Scientist, he has worked with all three life-forms in his 13-year research career, viz., particulate, unicellular and multicellular. He is currently an Assistant Scientist at Emory University (Atlanta, GA) studying mechanisms of tumor recurrence in kids with brain tumors. As a postdoctoral fellow, he was the recipient of two Young Investigator Awards from Alex Lemonade Stand Foundation (Philadelphia, PA) and Rockland Immunochemicals. His current research has been funded by Northwestern Mutual Foundation (Milwaukee, WI), CURE Childhood Cancer Foundation (Atlanta, GA) and American Association for Cancer Research (AACR). When he is not on the bench you will find him spending time with his family or exploring the world through traveling and blogging.
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