New Study Aims to Rapidly Test Lung Cancer Drugs

“A bold new way to test cancer drugs started Monday in hundreds of hospitals around the U.S. In a medical version of speed dating, doctors will sort through multiple experimental drugs and match patients to the one most likely to succeed based on each person’s unique tumor gene profile.

“It’s a first-of-a-kind experiment that brings together five drug companies, the government, private foundations and advocacy groups. The idea came from the federal Food and Drug Administration, which has agreed to consider approving new medicines based on results from the study.

“Its goal is to speed new treatments to market and give seriously ill patients more chances to find something that will help. Instead of being tested for individual genes and trying to qualify for separate clinical trials testing single drugs, patients can enroll in this umbrella study, get full gene testing and have access to many options at once.”

Editor’s note: Many patients enroll in clinical trials as volunteers to test new drugs they wouldn’t otherwise be able to get. But it can be difficult for patients to enroll on clinical trials, and even more difficult to enroll in ones that do a good job of taking into account the specific molecular characteristics of a patients’ tumor(s). Other aspects of traditional clinical trials make them inefficient and expensive, and it can take a long time for useful insights to emerge. The study described in this article attempts to overhaul clinical trial design for people with with advanced squamous non-small cell lung cancer (NSCLC). Each patient will have his or her tumor(s) checked for 200 specific mutations. Based on the combination of mutations, his or her oncologist will then be able to request certain experimental drugs for the patient to try. This will hopefully let more patients access their best treatment options faster, and it will allow oncologists to learn more rapidly about the effectiveness of different drugs in different patients.


Study of 'Super Responder' Reveals New Oncogene for Lung Cancer

“Researchers have taken the next step in confirming the identity of previously unknown gene mutation that drives lung cancer development. Scientists at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) originally identified the mutation in one patient out of nine with advanced lung cancer who responded well to the drug sorafenib. The clinical trial involved 306 participants total.

“Within two months of beginning treatment, the patient had demonstrated a near complete response, and she remained progression-free and asymptomatic for five years while continuing to take sorafenib by mouth.”

Editor’s note: Different patients’ tumors have different genetic mutations. More and more, doctors are using patients’ tumor genetics to match patients with treatments that are most likely to work for them. Now, researchers have discovered a mutation called S214C, which may help doctors predict some lung cancer patients’ responses to treatment. The mutation was found in a patient in a clinical trial who responded particularly well to a drug called sorafenib.


Cancer ‘Miracle’ Patients Studied Anew for Disease Clues

“The history of oncology is rife with reports of patients with advanced cancer who staged miraculous recoveries.

“Now scientists are starting to use sophisticated DNA sequencing technology to determine if these “exceptional responders” carry gene variations that can lead to new treatment approaches, better targeted therapies or even the re-emergence of experimental drugs once deemed failures.

“The mystery surrounding Jan Crisitello, a 70-year-old grandmother of four, is a case in point. Five years ago, 29 patients with advanced melanoma enrolled in a trial of a drug under development by Pfizer Inc. (PFE) Only one, Crisitello, came away with her cancer in remission. Now, she is being studied to see how her unique genome may have interacted with the drug to spur her recovery.”

Editor’s note: To learn more about personalized medicine, click here.


Cancer ‘Miracle’ Patients Studied Anew for Disease Clues

“The history of oncology is rife with reports of patients with advanced cancer who staged miraculous recoveries.

“Now scientists are starting to use sophisticated DNA sequencing technology to determine if these “exceptional responders” carry gene variations that can lead to new treatment approaches, better targeted therapies or even the re-emergence of experimental drugs once deemed failures.

“The mystery surrounding Jan Crisitello, a 70-year-old grandmother of four, is a case in point. Five years ago, 29 patients with advanced melanoma enrolled in a trial of a drug under development by Pfizer Inc. (PFE) Only one, Crisitello, came away with her cancer in remission. Now, she is being studied to see how her unique genome may have interacted with the drug to spur her recovery.”

Editor’s note: To learn more about personalized medicine, click here.


Cancer ‘Miracle’ Patients Studied Anew for Disease Clues

“The history of oncology is rife with reports of patients with advanced cancer who staged miraculous recoveries.

“Now scientists are starting to use sophisticated DNA sequencing technology to determine if these “exceptional responders” carry gene variations that can lead to new treatment approaches, better targeted therapies or even the re-emergence of experimental drugs once deemed failures.

“The mystery surrounding Jan Crisitello, a 70-year-old grandmother of four, is a case in point. Five years ago, 29 patients with advanced melanoma enrolled in a trial of a drug under development by Pfizer Inc. (PFE) Only one, Crisitello, came away with her cancer in remission. Now, she is being studied to see how her unique genome may have interacted with the drug to spur her recovery.”

Editor’s note: To learn more about personalized medicine, click here.


‘Early Access’ Scheme Unveiled for Innovative Medicines

“People with advanced cancer and other serious illnesses like dementia could soon benefit from early access to innovative and promising treatments.

“The Early Access to Medicines scheme would enable safe and promising drugs to be ‘fast tracked’ into the NHS before they have even been granted a licence for use.

“The new scheme will allow patients without other treatment options to be given experimental drugs that have not yet been licensed but that have been deemed safe and effective through clinical trials.

“Experts will carry out a rapid analysis of the treatment before labelling it a ‘promising innovative medicine’.

“The Medicines and Healthcare products Regulatory Agency (MHRA) will then offer a scientific opinion based on a medicine’s risks and benefits. If the benefits are found to outweigh the risks, doctors will be given the green light to offer the drug to patients.”

Editor’s Note: This UK program is similar to a program already in place in the US that allows patients to request access to drugs still being tested in clinical trials. Even though so-called “compassionate access” is possible, the process can be quite difficult for patients. Learn more about it  from our blog feature on the topic.


‘Early Access’ Scheme Unveiled for Innovative Medicines

“People with advanced cancer and other serious illnesses like dementia could soon benefit from early access to innovative and promising treatments.

“The Early Access to Medicines scheme would enable safe and promising drugs to be ‘fast tracked’ into the NHS before they have even been granted a licence for use.

“The new scheme will allow patients without other treatment options to be given experimental drugs that have not yet been licensed but that have been deemed safe and effective through clinical trials.

“Experts will carry out a rapid analysis of the treatment before labelling it a ‘promising innovative medicine’.

“The Medicines and Healthcare products Regulatory Agency (MHRA) will then offer a scientific opinion based on a medicine’s risks and benefits. If the benefits are found to outweigh the risks, doctors will be given the green light to offer the drug to patients.”

Editor’s Note: This UK program is similar to a program already in place in the US that allows patients to request access to drugs still being tested in clinical trials. Even though so-called “compassionate access” is possible, the process can be quite difficult for patients. Learn more about it  from our blog feature on the topic.


‘Early Access’ Scheme Unveiled for Innovative Medicines

“People with advanced cancer and other serious illnesses like dementia could soon benefit from early access to innovative and promising treatments.

“The Early Access to Medicines scheme would enable safe and promising drugs to be ‘fast tracked’ into the NHS before they have even been granted a licence for use.

“The new scheme will allow patients without other treatment options to be given experimental drugs that have not yet been licensed but that have been deemed safe and effective through clinical trials.

“Experts will carry out a rapid analysis of the treatment before labelling it a ‘promising innovative medicine’.

“The Medicines and Healthcare products Regulatory Agency (MHRA) will then offer a scientific opinion based on a medicine’s risks and benefits. If the benefits are found to outweigh the risks, doctors will be given the green light to offer the drug to patients.”


Listen: Marty Tenenbaum Featured in New Mendelspod Podcast

Cancer Commons founder Dr. Marty Tenenbaum is featured in a new podcast from Mendelspod. In the podcast, entitled “4 Reasons Clinical Trials Don’t Work,” Dr. Tenenbaum outlines the shortcomings of the current state of the clinical trial system, and offer solutions for improvement. Cancer Commons is key to his vision of a revamped cancer research system that focuses on individual cancer patients to find answers faster. Listen on the website, or download the podcast to listen later.