New Hope For Lung Cancer Patients: FDA Approval of Immunotherapy Drug For Use With Chemotherapy Prior to Surgery Hailed As ‘Major Advancement’

Approval of an immunotherapy agent is the FDA's first for prior to surgery treatment for early-stage NSCLC.

"Historically, early-stage lung cancers have been treated with surgery, plus chemotherapy administered before or after surgery to reduce the risk of recurrence," Dr. Benjamin Herzberg, a medical oncologist specializing in thoracic malignancies at Columbia University’s Herbert Irving Comprehensive Cancer Center, tells SurvivorNet. "Now, with the FDA approval of the immunotherapy drug nivolumabgiven alongside chemotherapy and prior to definitive surgerywe have another option to offer patients to reduce the risk of cancer coming back."

How The New 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%

"At NYU Perlmutter Cancer Center, several of our patients were on this trial and it is encouraging to see these results and the impact it has on our field,”  says Dr. Elaine Shum, medical oncologist at NYU Perlmutter Cancer Center and assistant professor of medicine at NYU Grossman School of Medicine.

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?

 

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