What’s Coming Down the Pike
Comments
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Good News..GSRon said:Here is another link from the
Here is another link from the recent ASCO Conference. This video tells a broader tale on the Ipi combo with Nivo. You Southern California people, may want to check out when this combo may show up at City of Hope.. Looks like there may be some difficult side effects, but the rewards should be well worth it.. You know I will be watching this combo..
http://cancergrace.org/kidney-cancer/2014/07/02/asco_2014_hottest_thing_late_stage_kidney/
Ron
Hi All.. in case you did not see this... soon we may have another weapon... Nivolumab..!!
Be Well All..!!
Ron
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BUMPGSRon said:Good News..
Hi All.. in case you did not see this... soon we may have another weapon... Nivolumab..!!
Be Well All..!!
Ron
Positive prospects!! Keep the faith everyone.
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SGN-CD70A
Looks Interesting - BDS
Seattle Genetics Initiates Phase 1 Clinical Trial of Antibody-Drug Conjugate SGN-CD70A for Non-Hodgkin Lymphoma and Renal Cell Carcinoma
BOTHELL, Wash.--(BUSINESS WIRE)--Aug. 12, 2014-- Seattle Genetics, Inc. (NASDAQ:SGEN) today announced the initiation of a phase 1 clinical trial evaluating SGN-CD70A for CD70-positive relapsed or refractory non-Hodgkin lymphoma (NHL) and metastatic renal cell carcinoma (RCC). SGN-CD70A is a novel antibody-drug conjugate (ADC) targeted to CD70 utilizing the company’s newest ADC technology. The phase 1 trial is designed to assess the safety and antitumor activity of SGN-CD70A.
“CD70 is a very promising ADC antigen, which is highly expressed in both NHL and RCC, and has minimal expression in healthy tissues,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development, at Seattle Genetics. “We are building on the single-agent activity we observed with our former SGN-75 candidate and have designed SGN-CD70A with a goal to have enhanced activity by utilizing our next-generation ADC technology. Our preclinical data demonstrate that this novel ADC is extremely potent in RCC and NHL models, and we are enthusiastic about commencing a clinical trial of SGN-CD70A in patients with a clear need for new therapeutic options.”
Seattle Genetics previously observed single-agent activity, including objective responses, in a phase 1 clinical trial with an initial CD70-targeted ADC called SGN-75 but did not observe enough activity to support further clinical development. To build on that experience, the company developed a next-generation anti-CD70 ADC utilizing its newest technology comprising a highly potent cytotoxic agent, called a pyrrolobenzodiazepine (PBD) dimer, stably linked to a CD70-directed antibody via proprietary site-specific conjugation technology. Preclinical data presented at the 2014 American Association of Cancer Research (AACR) annual meeting demonstrate SGN-CD70A induces targeted cell killing via DNA damage to treated tumors in both RCC and NHL models.
The new SGN-CD70A study is a phase 1, open-label, multi-center, dose-escalation clinical trial. The primary endpoints are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD70A. In addition, the trial will evaluate the antitumor activity and pharmacokinetics in patients with CD70-positive metastatic RCC or relapsed or refractory NHL, including mantle cell lymphoma and diffuse large B-cell lymphoma. The study is designed to evaluate SGN-CD70A administered every three weeks and will enroll approximately 95 patients at multiple centers in the United States.
ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. This approach is intended to spare non-targeted cells and reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.
Website:
http://www.seattlegenetics.com/
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Awesome.. thanks BDS..!BDS said:SGN-CD70A
Looks Interesting - BDS
Seattle Genetics Initiates Phase 1 Clinical Trial of Antibody-Drug Conjugate SGN-CD70A for Non-Hodgkin Lymphoma and Renal Cell Carcinoma
BOTHELL, Wash.--(BUSINESS WIRE)--Aug. 12, 2014-- Seattle Genetics, Inc. (NASDAQ:SGEN) today announced the initiation of a phase 1 clinical trial evaluating SGN-CD70A for CD70-positive relapsed or refractory non-Hodgkin lymphoma (NHL) and metastatic renal cell carcinoma (RCC). SGN-CD70A is a novel antibody-drug conjugate (ADC) targeted to CD70 utilizing the company’s newest ADC technology. The phase 1 trial is designed to assess the safety and antitumor activity of SGN-CD70A.
“CD70 is a very promising ADC antigen, which is highly expressed in both NHL and RCC, and has minimal expression in healthy tissues,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development, at Seattle Genetics. “We are building on the single-agent activity we observed with our former SGN-75 candidate and have designed SGN-CD70A with a goal to have enhanced activity by utilizing our next-generation ADC technology. Our preclinical data demonstrate that this novel ADC is extremely potent in RCC and NHL models, and we are enthusiastic about commencing a clinical trial of SGN-CD70A in patients with a clear need for new therapeutic options.”
Seattle Genetics previously observed single-agent activity, including objective responses, in a phase 1 clinical trial with an initial CD70-targeted ADC called SGN-75 but did not observe enough activity to support further clinical development. To build on that experience, the company developed a next-generation anti-CD70 ADC utilizing its newest technology comprising a highly potent cytotoxic agent, called a pyrrolobenzodiazepine (PBD) dimer, stably linked to a CD70-directed antibody via proprietary site-specific conjugation technology. Preclinical data presented at the 2014 American Association of Cancer Research (AACR) annual meeting demonstrate SGN-CD70A induces targeted cell killing via DNA damage to treated tumors in both RCC and NHL models.
The new SGN-CD70A study is a phase 1, open-label, multi-center, dose-escalation clinical trial. The primary endpoints are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD70A. In addition, the trial will evaluate the antitumor activity and pharmacokinetics in patients with CD70-positive metastatic RCC or relapsed or refractory NHL, including mantle cell lymphoma and diffuse large B-cell lymphoma. The study is designed to evaluate SGN-CD70A administered every three weeks and will enroll approximately 95 patients at multiple centers in the United States.
ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. This approach is intended to spare non-targeted cells and reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.
Website:
http://www.seattlegenetics.com/
RonAwesome.. thanks BDS..!
Ron
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New agents and new targets in renal cell carcinomaalice124 said:Great job BDS. Will hold in my favorites file for quick reference. Appreciate your compilation.
This information does not specifically mention the chromophobe renal cell carcinoma but it is referencing the research by the Cancer Genome Atlas which just revealed breakthrough information into the biology of chromophobe RCC. I've posted about this on another thread if you search for it but wanted to add it here and bump up this post, of course. Hope for all in this research, I believe. I put the last emphasis in bold myself.
Written by:
Philips GK, Atkins MB. Are you the author?
Department of Oncology, Georgetown-Lombardi Comprehensive Cancer Center and Division of Hematology/Oncology, Medstar Georgetown University Hospital, Washington, DC.The vascular endothelial growth factor (VEGF) pathway blockers and mammalian target of rapamycin (mTOR) inhibitors have dramatically improved the treatment options and outcome for patients with advanced renal cell carcinoma (RCC).
However, because the vast majority of patients will still succumb to their disease, novel treatment approaches are still necessary. Efforts to identify novel therapeutic target treatments are focused on better understanding unique aspects of tumor cell biology guided the Cancer Genome Atlas analyses and the interaction of the tumor with its microenvironment. Areas of promising investigation include a) the identification of mechanisms of acquired resistance to VEGF pathway inhibition and developing agents targeting these in combination with VEGF receptor (VEGFR) pathway blockade; b) the identification of novel therapeutic targets, particularly for patients with VEGF pathway blocker refractory disease; and c) the development of novel immunotherapies, particularly those involving checkpoint inhibitors used alone or in combination with other immunotherapies of VEGF pathway blockers. Specific targets or agents of interest include angiopoietins (trebaninib), c-Met (cabozantinib), activin receptor-like kinase-1 (ALK-1; dalantercept), interleukin (IL)-8, and HDM2 for acquired resistance to VEGF pathway inhibition; hypoxia inducible factor-2 alpha (HIF-2 alpha), TORC1/2, and the Hippo pathway for novel targets, and PD1 and PDL1 antibodies given either alone or in combination with other checkpoint inhibitors, other immunotherapies, or VEGF pathway blockers for novel immunotherapies. In addition, the application of genetic, immunologic, or other biomarkers developed in the context of this research has the potential to select patients with specific tumor types for therapy targeted to specific vulnerabilities within the tumor or tumor microenvironment. Together, these developments should enable the transition to a new era of rational and more effective therapy for patients with advanced RCC.
Written by:
Philips GK, Atkins MB. Are you the author?
Department of Oncology, Georgetown-Lombardi Comprehensive Cancer Center and Division of Hematology/Oncology, Medstar Georgetown University Hospital, Washington, DC.Reference: Am Soc Clin Oncol Educ Book. 2014:e222-7.
doi: 10.14694/EdBook_AM.2014.34.e222
PubMed Abstract
PMID: 248571060 -
An oversight that effects non-clear cell mRCC patientssblairc said:New agents and new targets in renal cell carcinoma
This information does not specifically mention the chromophobe renal cell carcinoma but it is referencing the research by the Cancer Genome Atlas which just revealed breakthrough information into the biology of chromophobe RCC. I've posted about this on another thread if you search for it but wanted to add it here and bump up this post, of course. Hope for all in this research, I believe. I put the last emphasis in bold myself.
Written by:
Philips GK, Atkins MB. Are you the author?
Department of Oncology, Georgetown-Lombardi Comprehensive Cancer Center and Division of Hematology/Oncology, Medstar Georgetown University Hospital, Washington, DC.The vascular endothelial growth factor (VEGF) pathway blockers and mammalian target of rapamycin (mTOR) inhibitors have dramatically improved the treatment options and outcome for patients with advanced renal cell carcinoma (RCC).
However, because the vast majority of patients will still succumb to their disease, novel treatment approaches are still necessary. Efforts to identify novel therapeutic target treatments are focused on better understanding unique aspects of tumor cell biology guided the Cancer Genome Atlas analyses and the interaction of the tumor with its microenvironment. Areas of promising investigation include a) the identification of mechanisms of acquired resistance to VEGF pathway inhibition and developing agents targeting these in combination with VEGF receptor (VEGFR) pathway blockade; b) the identification of novel therapeutic targets, particularly for patients with VEGF pathway blocker refractory disease; and c) the development of novel immunotherapies, particularly those involving checkpoint inhibitors used alone or in combination with other immunotherapies of VEGF pathway blockers. Specific targets or agents of interest include angiopoietins (trebaninib), c-Met (cabozantinib), activin receptor-like kinase-1 (ALK-1; dalantercept), interleukin (IL)-8, and HDM2 for acquired resistance to VEGF pathway inhibition; hypoxia inducible factor-2 alpha (HIF-2 alpha), TORC1/2, and the Hippo pathway for novel targets, and PD1 and PDL1 antibodies given either alone or in combination with other checkpoint inhibitors, other immunotherapies, or VEGF pathway blockers for novel immunotherapies. In addition, the application of genetic, immunologic, or other biomarkers developed in the context of this research has the potential to select patients with specific tumor types for therapy targeted to specific vulnerabilities within the tumor or tumor microenvironment. Together, these developments should enable the transition to a new era of rational and more effective therapy for patients with advanced RCC.
Written by:
Philips GK, Atkins MB. Are you the author?
Department of Oncology, Georgetown-Lombardi Comprehensive Cancer Center and Division of Hematology/Oncology, Medstar Georgetown University Hospital, Washington, DC.Reference: Am Soc Clin Oncol Educ Book. 2014:e222-7.
doi: 10.14694/EdBook_AM.2014.34.e222
PubMed Abstract
PMID: 24857106However, as regards the new Chromophobe study (and likely true of all cancers), the key part of that research was the finding that the roll of the Mitochondria and mDNA (Mitochondrial DNA) needs to be considered and may be far more important.
The Cancer Genome Atlas has been primarily concerned (up to now) with the Nucleus and nuclear DNA. The above paper makes no mention of yet to be introduced metabolic therapies (which are certainly novel) for this reason.
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Ribavirin
Anti-tumor effect of ribavirin in combination with interferon-alpha on renal cell carcinoma cell lines in vitro
Lichen Teng, Dexin Ding, Yongsheng Chen, Hongshuang Dai, Guobin Liu, Zhongjie Qiaoand Ruihua An
Cancer Cell International 2014, 14:63 doi:10.1186/1475-2867-14-63
Published: 3 September 2014Abstract (provisional)
Background
Ribavirin is an anti-viral drug; however, recent data suggest that it may also be effective in cancer therapy. This study investigated the effect of ribavirin alone or in combination with IFN-alpha on biological processes: proliferation, apoptosis, and migration of murine (Renca) and human renal carcinoma (RCC) cells (786-0) in vitro.
Methods
Renca and 786-0 cells were treated with IFN-alpha, ribavirin, or a combination of IFN-alpha and ribavirin at varying concentrations. Cell proliferation was evaluated using CCK-8 assay. Induction of apoptosis and distribution of cell cycle were determined by flow cytometry. The migratory capacity of cells was quantified using a transwell migration assay. The toxic effect of these drugs was examined using MTT assay in HEK-293 cells. ELISA was used to measure IL-10 and TGF-beta content in the culture supernatants.
Results
Our results showed that both ribavirin alone and in combination with IFN-alpha could significantly inhibit the cell proliferation and arrest the cell cycle progress at the G2/M phase. These treatments also inhibited cell migration and IL-10 production, in a concentration-dependent manner, in 786-0 and Renca cells. Moreover, they significantly induced apoptosis of RCC cells and increased TGF-beta production in concentration-dependent manner. No significant toxic effect was observed in HEK-293 cells. We also found that the effect of combined treatment was more pronounced than that of ribavirin or IFN-alpha alone. However, the combined effect of the two drugs was not synergistic.
Conclusion
Our findings suggest that ribavirin can negatively affect biological processes of RCC cells. This agent might become a new candidate for the treatment of RCC in the clinical setting.
The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
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Pembrolizumab (MK-3475) receives FDA Approval.
The U.S. Food and Drug Administration has just approved Merck's immunotherapy pembrolizumab as a new treatment for advanced melanoma.
Merck will sell the drug under the brand name Keytruda. The drug works by blocking a cellular pathway known as PD-1 which is used as cloaking mechanism used by cancer cells to hide from a patient's immune system. Similar anti-PD-1 and anti-PD-L1 drugs are being developed most notably by Bristol-Myers Squibb, Roche and AstraZeneca.
Bristol's PD-1 inhibitor nivolumab (brand name: Opdivo) was approved in Japan recently and is awaiting U.S. approval.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm
It’s another step in the right direction. Clinical Trials for Renal Cell are opening up - BDS
From Fiercebiotech
But the biggest promise for PD-1 blockers--both clinically and commercially--likely lies in combination therapies, and Merck has launched a fleet of cocktail studies that match pembrolizumab with treatments from Pfizer, Amgen, Incyte and others in hopes of bolstering the drug's stirring potential as a monotherapy. Its competitors have followed suit, and the coming years are likely to see a host of PD-1 treatments approved for use in tandem with other therapies in a variety of cancers.
In the near term, Bristol-Myers is closest on Merck's heels in the U.S., submitting its PD-1 candidate for FDA scrutiny in July. Roche and AstraZeneca are not far behind with their contenders, and each company is banking on the agency following through on its promise of swift reviews for the breakthrough class of therapies.
Pembrolizumab's nod marks the 6th approval for a melanoma treatment since 2011, according to the FDA, reflecting both the explosion of research advances in the field and the series of the disease. Melanoma accounts for about 5% of all new cancers in the U.S., the agency said, killing nearly 10,000 people each year.
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You beat me to it.. but hereBDS said:Pembrolizumab (MK-3475) receives FDA Approval.
The U.S. Food and Drug Administration has just approved Merck's immunotherapy pembrolizumab as a new treatment for advanced melanoma.
Merck will sell the drug under the brand name Keytruda. The drug works by blocking a cellular pathway known as PD-1 which is used as cloaking mechanism used by cancer cells to hide from a patient's immune system. Similar anti-PD-1 and anti-PD-L1 drugs are being developed most notably by Bristol-Myers Squibb, Roche and AstraZeneca.
Bristol's PD-1 inhibitor nivolumab (brand name: Opdivo) was approved in Japan recently and is awaiting U.S. approval.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm
It’s another step in the right direction. Clinical Trials for Renal Cell are opening up - BDS
From Fiercebiotech
But the biggest promise for PD-1 blockers--both clinically and commercially--likely lies in combination therapies, and Merck has launched a fleet of cocktail studies that match pembrolizumab with treatments from Pfizer, Amgen, Incyte and others in hopes of bolstering the drug's stirring potential as a monotherapy. Its competitors have followed suit, and the coming years are likely to see a host of PD-1 treatments approved for use in tandem with other therapies in a variety of cancers.
In the near term, Bristol-Myers is closest on Merck's heels in the U.S., submitting its PD-1 candidate for FDA scrutiny in July. Roche and AstraZeneca are not far behind with their contenders, and each company is banking on the agency following through on its promise of swift reviews for the breakthrough class of therapies.
Pembrolizumab's nod marks the 6th approval for a melanoma treatment since 2011, according to the FDA, reflecting both the explosion of research advances in the field and the series of the disease. Melanoma accounts for about 5% of all new cancers in the U.S., the agency said, killing nearly 10,000 people each year.
You beat me to it.. but here are two more links worth a read.. Hang on people.. more help is on the way..!!
http://www.onclive.com/web-exclusives/FDA-Approves-Pembrolizumab-for-Advanced-Melanoma
Ron
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Prescribed "off label"GSRon said:You beat me to it.. but here
You beat me to it.. but here are two more links worth a read.. Hang on people.. more help is on the way..!!
http://www.onclive.com/web-exclusives/FDA-Approves-Pembrolizumab-for-Advanced-Melanoma
Ron
Forgive me if this has come up before: Can the drug approved for Melanoma be proscribed for kidney cancer if they think it might work?
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CBS News FDA approves first-of-its-kind cancer drug for melanomaBDS said:Pembrolizumab (MK-3475) receives FDA Approval.
The U.S. Food and Drug Administration has just approved Merck's immunotherapy pembrolizumab as a new treatment for advanced melanoma.
Merck will sell the drug under the brand name Keytruda. The drug works by blocking a cellular pathway known as PD-1 which is used as cloaking mechanism used by cancer cells to hide from a patient's immune system. Similar anti-PD-1 and anti-PD-L1 drugs are being developed most notably by Bristol-Myers Squibb, Roche and AstraZeneca.
Bristol's PD-1 inhibitor nivolumab (brand name: Opdivo) was approved in Japan recently and is awaiting U.S. approval.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm
It’s another step in the right direction. Clinical Trials for Renal Cell are opening up - BDS
From Fiercebiotech
But the biggest promise for PD-1 blockers--both clinically and commercially--likely lies in combination therapies, and Merck has launched a fleet of cocktail studies that match pembrolizumab with treatments from Pfizer, Amgen, Incyte and others in hopes of bolstering the drug's stirring potential as a monotherapy. Its competitors have followed suit, and the coming years are likely to see a host of PD-1 treatments approved for use in tandem with other therapies in a variety of cancers.
In the near term, Bristol-Myers is closest on Merck's heels in the U.S., submitting its PD-1 candidate for FDA scrutiny in July. Roche and AstraZeneca are not far behind with their contenders, and each company is banking on the agency following through on its promise of swift reviews for the breakthrough class of therapies.
Pembrolizumab's nod marks the 6th approval for a melanoma treatment since 2011, according to the FDA, reflecting both the explosion of research advances in the field and the series of the disease. Melanoma accounts for about 5% of all new cancers in the U.S., the agency said, killing nearly 10,000 people each year.
http://www.cbsnews.com/news/fda-approves-first-of-its-kind-cancer-drug-for-melanoma/
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sblairc, the answer is yes itsblairc said:Prescribed "off label"
Forgive me if this has come up before: Can the drug approved for Melanoma be proscribed for kidney cancer if they think it might work?
sblairc, the answer is yes it can be perscribed, but getting the insurance company to pay for it may be a different issue. But there are a bunch of clinical trials that are out there.. suggest you check them out. There are some combination trials that show a lot more promise than the individual drug.
Ron
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Oh, This Could Spell Trouble!
Published on FiercePharma (http://www.fiercepharma.com)
Bristol-Myers socks Merck's brand-new Keytruda with PD-1 patent suit
September 8, 2014 | By Tracy Staton
Bristol-Myers Squibb is doing its best to rain on Merck & Co.'s immunotherapy parade. No sooner had Merck won FDA approval for its brand-new cancer drug KeyTruda (pembrolizumab) than Bristol-Myers and its partner Ono Pharmaceutical slapped it with a patent-infringement lawsuit.
If the Delaware federal court buys Bristol-Myers' argument, that could spell trouble for not only Merck, but other rivals developing a new generation of cancer immonotherapies known as PD-1 blockers. It's the hottest field in oncology these days, with AstraZeneca and Roche among those racing to get their therapies to market.
The U.S. patent in question--granted to Ono May 20 and licensed to Bristol-Myers--covers the use of anti-PD-1 antibodies to treat cancer. According to the lawsuit, Merck was not first to the PD-1 game. Bristol-Myers and Ono claim that Merck started developing Keytruda after they'd already made progress with their own Opdivo (nivolumab), approved earlier this year in Japan, but not yet in the U.S.
"Merck is threatening to exploit that invention with a later-developed anti-PD-1 antibody," the lawsuit claims.
The lawsuit asks for damages, but more importantly, asks the court to declare that Merck infringes that PD-1 patent. Such a decision would bolster Bristol-Myers and Ono's argument that they are owed royalties on sales of rival PD-1 drugs. The companies are fighting a similar battle in Europe, The Wall Street Journal notes, and analysts at Credit Suisse have said that the two companies could eventually reap significant royalties from their suite of PD-1 patents.
Merck, for its part, has acknowledged that Ono won the method patent, but also says that it's invalid. After the lawsuit was filed at the end of last week, the company said the complaint won't interfere with its launch of Keytruda, now approved to treat melanoma in the U.S. Priced at $12,500 per month--or about $150,000 per year--the drug is obviously expensive, but with impressive results in clinical trials, it's expected to be adopted quickly. Analysts see it hitting $1.8 billion by 2017.
Bristol-Myers priced Opdivo at $143,000 in Japan last week, and it, too, is expected to soar to blockbuster status. The company says it plans to file for FDA approval in melanoma by the end of this quarter, with a decision targeted for mid-2015.
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INTUVAX Vaccine
Immunicum presents updated survival data for INTUVAX-treated renal cancer patients
September 12, 2014 06:58 ET | Source:Immunicum AB
Gothenburg, Sweden, 2014-09-12 12:58 CEST (GLOBE NEWSWIRE) -- Immunicum AB (publ) today announced that updated survival data from a completed Phase I/II study of INTUVAX will be presented on September 15 at the 3rd Annual Cancer Vaccines Conference in London. In this study, the therapeutic cancer vaccine INTUVAX is evaluated in patients with metastatic renal cell cancer.
The purpose of the study was to document the safety profile, the immunological response and to monitor the survival of patients with metastatic renal cell carcinoma after treatment with two INTUVAX injections.
The new survival data to be presented at the conference reveals that 7 out of 11 evaluable patients are still alive.
The median survival in a subgroup of five patients who were classified as high-risk patients is now exceeding 17 months. Two of these patients, one of whom is still alive, have achieved a survival of more than two years. This compares with an expected median survival of nine months following current standard treatment for this population – the tyrosine kinase inhibitor sunitinib. Notably, none of the high-risk patients in the INTUVAX study received tyrosine kinase inhibitors during the first nine months after vaccination.
Continued monitoring is necessary to clarify the survival rate among patients who have a slightly less aggressive disease (intermediate mRCC). The updated survival data show that five out of six patients in this subgroup are still alive. For three of these, survival is now exceeding 21 months.
In three out of four patients that received add-on treatment with tyrosine kinase inhibitors due to tumor growth, decreases of tumor size were noted. In two of these patients, this was particularly unexpected, as their tumor types (metastatic brain tumors and metastases in extensive sarcomatoid tumor transformation) rarely respond to treatment with sunitinib. Examinations with computed tomography (CT scan) indicate that all brain metastases have now disappeared.
"The study results indicate that the extended survival is a result of INTUVAX’ ability to achieve a tumor-specific immune response, that appears to inhibit the rate of growth in the tumor metastases. Preliminary data suggests that subsequent adjunctive treatment with tyrosine kinase inhibitors may enhance the anti-tumoral effect in a synergistic way," says Dr. Alex Karlsson-Parra, Chief Scientific Officer at Immunicum.
"INTUVAX seems to prolong the survival of those renal cell cancer patients initially considered to have the worst prognosis. For patients with a less aggressive disease, longer follow-up is needed, but the current data is promising even in this group of patients. We look forward to soon start a Phase II trial, in order to progress INTUVAX towards a market registration as quickly as possible," says Jamal El-Mosleh, CEO of Immunicum.
The above data will also be presented at the 22nd Annual International Cancer Immunotherapy Symposium in New York, which will be held on October 6 to 8.
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Using tumor tissue after neprhectomyBDS said:INTUVAX Vaccine
Immunicum presents updated survival data for INTUVAX-treated renal cancer patients
September 12, 2014 06:58 ET | Source:Immunicum AB
Gothenburg, Sweden, 2014-09-12 12:58 CEST (GLOBE NEWSWIRE) -- Immunicum AB (publ) today announced that updated survival data from a completed Phase I/II study of INTUVAX will be presented on September 15 at the 3rd Annual Cancer Vaccines Conference in London. In this study, the therapeutic cancer vaccine INTUVAX is evaluated in patients with metastatic renal cell cancer.
The purpose of the study was to document the safety profile, the immunological response and to monitor the survival of patients with metastatic renal cell carcinoma after treatment with two INTUVAX injections.
The new survival data to be presented at the conference reveals that 7 out of 11 evaluable patients are still alive.
The median survival in a subgroup of five patients who were classified as high-risk patients is now exceeding 17 months. Two of these patients, one of whom is still alive, have achieved a survival of more than two years. This compares with an expected median survival of nine months following current standard treatment for this population – the tyrosine kinase inhibitor sunitinib. Notably, none of the high-risk patients in the INTUVAX study received tyrosine kinase inhibitors during the first nine months after vaccination.
Continued monitoring is necessary to clarify the survival rate among patients who have a slightly less aggressive disease (intermediate mRCC). The updated survival data show that five out of six patients in this subgroup are still alive. For three of these, survival is now exceeding 21 months.
In three out of four patients that received add-on treatment with tyrosine kinase inhibitors due to tumor growth, decreases of tumor size were noted. In two of these patients, this was particularly unexpected, as their tumor types (metastatic brain tumors and metastases in extensive sarcomatoid tumor transformation) rarely respond to treatment with sunitinib. Examinations with computed tomography (CT scan) indicate that all brain metastases have now disappeared.
"The study results indicate that the extended survival is a result of INTUVAX’ ability to achieve a tumor-specific immune response, that appears to inhibit the rate of growth in the tumor metastases. Preliminary data suggests that subsequent adjunctive treatment with tyrosine kinase inhibitors may enhance the anti-tumoral effect in a synergistic way," says Dr. Alex Karlsson-Parra, Chief Scientific Officer at Immunicum.
"INTUVAX seems to prolong the survival of those renal cell cancer patients initially considered to have the worst prognosis. For patients with a less aggressive disease, longer follow-up is needed, but the current data is promising even in this group of patients. We look forward to soon start a Phase II trial, in order to progress INTUVAX towards a market registration as quickly as possible," says Jamal El-Mosleh, CEO of Immunicum.
The above data will also be presented at the 22nd Annual International Cancer Immunotherapy Symposium in New York, which will be held on October 6 to 8.
RIGHT ON!! Is this one of the vaccines where they use tumor tissue? Just wanting to know so that if it is people on here reading this understand what that process entails (most here won't benefit from this if it is the case but for anyone getting surgery soon it would be great to know!)
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INTUVAX
Immunicum reports continued promising survival data for INTUVAX
Gothenburg, Sweden, 2014-12-03 08:30 CET (GLOBE NEWSWIRE) -- Immunicum AB (publ) today announced continued promising data from a phase I/II trial in patients with metastatic renal cell carcinoma. The median survival in the subgroup of five individuals who were initially classified as high-risk patients now stands at 19.8 months, compared with an expected median survival of nine months following current standard therapy. Seven of the eleven evaluable patients in the study, of which two belong to the original group of five high-risk patients, are still alive.
In total, six of eleven patients have now received add-on therapy with tyrosine kinase inhibitors (TKI) due to tumor growth. Three of these patients (all with massive infiltration of CD8+ T cells in the removed kidney tumor) have noted a pronounced and prolonged regression of metastases.
Continued monitoring is necessary to clarify the effect on survival in patients with a slightly less aggressive disease (intermediate mRCC). Five of the six patients in this subgroup are still alive, three of which have achieved a survival time of more than two years.
– It is gratifying that the median survival in the INTUVAX-treated renal cancer patients continues to increase. We are now preparing a comprehensive phase II study in the same indication and expect this to be able to start in early 2015, says Immunicum’s CEO, Jamal El-Mosleh.
The purpose of the phase I/II study was to document the adverse event profile and immunological effects, and to follow the survival of patients with metastatic renal cell carcinoma after treatment with two INTUVAX injections.0 -
pikeBDS said:INTUVAX
Immunicum reports continued promising survival data for INTUVAX
Gothenburg, Sweden, 2014-12-03 08:30 CET (GLOBE NEWSWIRE) -- Immunicum AB (publ) today announced continued promising data from a phase I/II trial in patients with metastatic renal cell carcinoma. The median survival in the subgroup of five individuals who were initially classified as high-risk patients now stands at 19.8 months, compared with an expected median survival of nine months following current standard therapy. Seven of the eleven evaluable patients in the study, of which two belong to the original group of five high-risk patients, are still alive.
In total, six of eleven patients have now received add-on therapy with tyrosine kinase inhibitors (TKI) due to tumor growth. Three of these patients (all with massive infiltration of CD8+ T cells in the removed kidney tumor) have noted a pronounced and prolonged regression of metastases.
Continued monitoring is necessary to clarify the effect on survival in patients with a slightly less aggressive disease (intermediate mRCC). Five of the six patients in this subgroup are still alive, three of which have achieved a survival time of more than two years.
– It is gratifying that the median survival in the INTUVAX-treated renal cancer patients continues to increase. We are now preparing a comprehensive phase II study in the same indication and expect this to be able to start in early 2015, says Immunicum’s CEO, Jamal El-Mosleh.
The purpose of the phase I/II study was to document the adverse event profile and immunological effects, and to follow the survival of patients with metastatic renal cell carcinoma after treatment with two INTUVAX injections.BDS, I always like your updates on what's coming down the pike. From diagnosis to long term treatment, it makes me think about the difference in interest there is between someone newly diagnosed and someone still having challenges years later. With kidney cancer, the stage that someone is in, is really important. Having a 2.5 cm tumor removed is much more promising than having a double digit sized tumor with identifiable mets. But I think that percieving renal cell carcinoma as a chronic and treatable disease makes us all more optimistic. It's good toknow what is happening out there.
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