Comment policy

Commenting

We want to make sure BioLogical provides a good experience for all visitors. Therefore, we want to keep the content focused on the specific topics being addressed. Comments that don’t directly relate to MedImmune, AstraZeneca or the topics currently being discussed, or comments or questions about specific products (whether or not AstraZeneca/MedImmune products) or ongoing legal or regulatory matters may not be published or may be removed. If you have questions about MedImmune or AstraZeneca products, please get in touch. We reserve the right to not publish or to remove comments that are obscene, inflammatory, disrespectful, contain profanity, or that we deem are otherwise inappropriate. We may not publish or may remove comments that could be misleading or confusing, or thinly disguised sales pitches for other products or services. Additionally, we may not publish or may remove a link contained in your comment if it does not meet the criteria. However, BioLogical is about engagement so if we feel that a response is warranted, we will do our best to respond to your comments within three working days.

Follow-Up

We want to hear your stories, viewpoints and opinions – even if they are contradictory to ours. We do require that you include an email address so we may follow up with you if needed. Your email address will only be used to contact you regarding your posting. Please refer to AstraZeneca/MedImmune’s Privacy Statement for more information.

Side Effects

In order to monitor the safety of MedImmune (MedImmune Specialty Care) and AstraZeneca products, we encourage reporting any side effects experienced while taking a MedImmune or AstraZeneca product.

  • In the United States, adverse events/side effects can be reported to FDA by visiting www.FDA.gov/medwatch or by calling FDA at 1-800-FDA-1088. Alternatively, you may report this directly to MedImmune by calling 1-877-633-4411 or AstraZeneca (in the US only) by calling 1-800-236-9933.
  • Outside the United States, countries worldwide may have specific processes in place to handle reports of adverse events. To report an adverse event, ask your health care provider for more information or contact your local health authority.

Other Information

The content on BioLogical is for information purposes only and is not intended to be a substitute for professional medical advice. The comments on BioLogical come from the public and do not necessarily reflect the views of MedImmune or AstraZeneca. MedImmune and AstraZeneca do not endorse or approve the contents of such comments.

Any communications or information submitted through BioLogical, including comments, questions, data, ideas or know-how shall be deemed to be non-confidential and shall become the property of MedImmune/AstraZeneca, without compensation to the provider of such submissions. MedImmune and AstraZeneca shall have no obligation of any kind with respect to such information and may reproduce, publish, disclose, and distribute to others all or any part of such information, without limitation, for any purpose whatsoever. MedImmune/AstraZeneca shall be free to use any ideas, concepts, know-how, techniques or inventions contained therein for any purpose, including but not limited to developing, manufacturing and marketing products and services.

Please note, when a comment is published on BioLogical, your name will appear above it, not your username.

Sharing our cutting edge science and passion for innovation


Last updated: 06/17/2014

Lung-MAP: A Revolutionary Approach for Patient Trials

By Jun 17, 2014
Bahija Jallal

This week, MedImmune and AstraZeneca were pleased to be among a group of organizations that announced the Lung Cancer Master Protocol, or Lung-MAP, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer.  Its primary goal: to match patients with promising new cancer treatments based on their unique tumor profiles.

This is truly a groundbreaking collaboration, which has the potential to change and accelerate the way new biomarker-defined therapies are tested and approved for lung cancer—and, we hope, eventually for many other diseases that include other types of cancer. 

To deliver on this ambitious effort, it requires strong collaboration and we have this with a group of several public and private entities that includes the National Cancer Institute, South West Oncology Group (SWOG) Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health, Foundation Medicine, and five pharmaceutical companies that include AstraZeneca, MedImmune, Amgen, Genentech and Pfizer.

Much of the excitement for all of us involved in this effort centers on the use of a diagnostic platform for genomic profiling, and immune profiling that is conducted to match patients to one of several different investigational treatments.  The trial will initially test five experimental drugs—four targeted therapies that include MEDI4736, our anti-PD-L1 immunotherapy molecule, and AZD4547, AstraZeneca’s FGFR inhibitor.  We anticipate that between 500 and 1000 patients will be screened per year for more than 200 cancer-related genes for genomic alterations.  The results of this test will be used to assign each patient to the trial arm that best matches his or her tumor’s genomic profile.  

One of our key company priorities is to bring innovative new treatments to patients in need as quickly as possible, which is why we’re so thrilled to be part of this exciting new paradigm in oncology drug development.

Squamous cell carcinoma has a high mortality rate and represents about a quarter of all lung cancer diagnoses, but there are few treatment options other than chemotherapy. This approach to clinical testing should not only improve access to promising drugs but also ease the significant recruitment and infrastructure burdens on researchers involved in traditional clinical trials.

For example, a typical trial for a targeted therapy tests each potential patient for a single biomarker and enrolls only a portion—sometimes a very small portion—of those who are tested. Lung-MAP will simultaneously test patients for many biomarkers to assess eligibility for several different experimental treatments. Then, the patients who have been tested will be enrolled into one of Lung-MAP’s five trial arms based on their genomic profile.  This saves the patient and the physician the trouble of doing multiple invasive testing to qualify for the right study.

It is the first Phase II/III program to incorporate a broad diagnostic platform, and it represents true innovation in study design and personalized healthcare.  We’re matching the right patient with the right molecule based upon the profile of the tumor. This is an extremely tailored approach that we hope will have a meaningful impact on cancer therapy.

If you’d like to learn more about this important trial, you can visit www.Lung-MAP.org.

Comments

Leave a comment

BioLogical is MedImmune’s blog that offers a peek into our innovative science and inspiring employees.

Read comment policy