Treatment for Non-Small Cell Lung Cancer
- For people with earlier stage lung cancer that can potentially be taken out with surgery, the FDA has approved the immunotherapy drug nivolumab (brand name Opdivo) for use with chemotherapy prior to surgery.
- This is a new sequencing of treatment for lung caner patients for whom surgery is an option.
- Opdivo helps the body reignite it’s defense against cancer by actually blocking a part of the immune system which is preventing the body from fighting cancer. This is called check-point inhibition and it works much more effectively when a protein called PDL-1 is present in higher amounts.
- According to experts, it is important to ask your doctor whether this new treatment sequencing could be right for you and whether testing of your tumor from a biopsy reveals anything about the characteristics of the cancer which might help the decision making process for the use of immunotherapy.
The Food and Drug Administration has approved nivolumab (brand name Opdivo), for use with chemotherapy in treating non-small cell lung cancer (NSCLC) prior to surgery. The National Comprehensive Cancer Network Lung Cancer Panel also recommends the drug combo for eligible patients.
Read MoreHow This Treatment Combo Got Approved
The FDA's decision was based on findings from CHECKMATE-816, a clinical trial for patients with Stage IB, II, or IIIA NSCLC.- The study compared the outcomes of 358 individuals receiving nivolumab plus chemotherapy with those receiving chemotherapy only.
- The phase 3 findings show that patients showed better responses to treatment with nivolumab plus chemotherapy compared to just chemotherapy.
- The median time until disease progression (also known as event-free survival or EFS) in the nivolumab plus chemotherapy arm of the study was 31.6 months, compared to 20.8 months in the chemotherapy only arm.
- When cancer tissue is removed after therapy prior to surgery, doctors look for signs of cancer cells. If no such cells are found, the result is known as pCR. The pCR rate for the nivolumab plus chemotherapy group was 24 percent, while the chemotherapy only group achieved a 2.2 percent pCR rate.
- After one year follow-up, the estimated percentage of patients surviving without disease progression or disease recurrence was 76.1% with nivolumab plus chemotherapy and 63.4% with chemotherapy alone; at two years, the percentages were 63.8% and 45.3%
The study results also showed that the safety of surgery is not negatively impacted by the addition of nivolumab. A larger number of patients could get the cancer surgically-removed without needing the entire lung removed given shrinkage of the tumor by preop therapy.
The recommended dose is 360 mg with platinum-doublet chemotherapy on the same day for three 3-week cycles.
The Anatomy of a Lung Cancer
Earlier Immunotherapy for Lung Cancer
Cancer immunotherapy allows full activation of the body's immune system by removing brakes. Immunotherapy is different from chemotherapy. It harnesses the power of your immune system to target your cancer. When doctors recommend immunotherapy for early-stage lung cancer, they're usually talking about checkpoint inhibitors.
Here's how this treatment works:
- Checkpoints are proteins on the surface of T cells, a type of immune cell. T cells attack harmful substances such as bacteria, viruses, and cancer cells. PD-1 is an example of a checkpoint.
- Lung cancer cells have their own protein, PD-L1, that activates PD-1 and tells the T cell to ignore them. You can think of PD-L1 as a cloak that hides the cancer cell from the immune system.
- The interaction between PD-1 and PD-L1 is like a switch that shuts off the immune response.
- Immunotherapy drugs called PD-1 and PD-L1 inhibitors flip the switch. They block these proteins to switch the immune response back on so that your immune system can kill the cancer cells.
One potential advantage of giving immunotherapy before as opposed to after surgery is that there is more tumor available more "teaching material" for the now fully-activated immune cells to recognize. After surgery, if the immune cells see cancer cells emerging they are trained to act and destroy.
"The approval of neoadjuvant nivolumab with chemotherapy for early-stage lung cancer patients is a major advancement for our lung cancer patients by moving immunotherapy even earlier in our treatment paradigm, thus allowing more of our lung cancer patients to benefit from immunotherapy," Dr. Shum says. "The recent focus on drug approvals for early-stage lung cancer is an exciting milestone for patients as we continue to explore novel ways to further decrease the risk of recurrence and underscores the importance of lung cancer screening to detect early-stage lung cancer."
Dr. Herzberg adds that the nivolumab approval is just the latest in an encouraging trend toward the expanded use of immunotherapy for lung cancer treatment. "This marks the third FDA approval of an immunotherapy drug for localized lung cancers, and the second in the past year," he says. "For most patients with a localized lung cancer, and without a mutation in driver genes like EGFR or ALK, it is likely that immunotherapy will be an integral part of their treatment going forward."
Questions to Ask Your Doctor
- Is my lung cancer operable (resectable), and is neoadjuvant therapy appropriate?
- If so, I a good candidate for immunotherapy, such as nivolumab?
- How long will this type of therapy prior to surgery (neoadjuvant therapy) take?
- What impact should the treatment have on surgery?
- What are the most common side effects of nivolumab? Are there other risks?
- How and when will we know if nivolumab has been effective?
What Happens When You Are First Diagnosed With Lung Cancer?
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