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ImmunotherapyLung Cancer

Immunotherapy plus Chemotherapy a New Standard of Care for Patients with Extensive-Stage Small-Cell Lung Cancer

About 15% of lung cancers are small-cell lung cancer, and about one-third of those are extensive-stage small-cell lung cancer. In March 2020, the FDA approved the first immunotherapy, for use with chemotherapy, for first-line treatment of patients with extensive-stage small-cell lung cancer.
August 2020 – Immunotherapy
Phoebe Starr

Patients with a type of lung cancer called extensive-stage small-cell lung cancer now have a new first-line treatment option with immunotherapy in combination with chemotherapy. This new combination has shown to improve survival for these patients, who don’t have many treatment options and whose prognosis is less than 5 years.

About 15% of lung cancers are small-cell lung cancer. The majority, about 85%, of lung cancers are non–small-cell lung cancer. Recently, many immunotherapies that have been approved by the FDA for lung cancer are for non–small-cell lung cancer, not small-cell lung cancer. About two-thirds (33%) of patients who are diagnosed with small-cell lung cancer have extensive-stage disease.

Updated results of the phase 3 clinical trial CASPIAN continue to show that adding the immunotherapy Imfinzi (durvalumab), a PD-L1 inhibitor, to standard chemotherapy prolongs overall survival in patients with newly diagnosed extensive-stage small-cell lung cancer, according to Luis G. Paz-Ares, MD, PhD, Chair of the Medical Oncology Department at Hospital Universitario in Madrid, Spain.

Ronit Yarden, PhD, MHSA

“This is an effective first-line treatment in the extensive-stage setting, where improving outcomes has been a challenge, and so few patients survive 5 years,” said Dr. Paz-Ares, who led the CASPIAN clinical trial and presented the updated results at the 2020 virtual meeting of the American Society of Clinical Oncology.

“The results support the use of the PD-L1 inhibitor in combination with etoposide plus either cisplatin or carboplatin as a new frontline standard of care for this patient population.”

Imfinzi Approved for Small-Cell Lung Cancer

Based on the results from the CASPIAN study, in March 2020 the FDA approved the use of Imfinzi immunotherapy in combination with etoposide chemotherapy plus cisplatin or carboplatin chemotherapy, as first-line therapy for patients with extensive-stage small-cell lung cancer. This is the first immunotherapy approved for the treatment of patients with this type of small-cell lung cancer, who have few treatment options.

Although most (about 80%) patients with extensive-stage small-cell lung cancer initially respond to standard chemotherapy with cisplatin or carboplatin, within 6 months of treatment the cancer relapses in the majority of the patients.

Before the approval of this immunotherapy plus chemotherapy combination, the average overall survival for patients with this type of small-cell lung cancer was 10 months.

Improved Survival

This updated analysis of the CASPIAN study confirms the long-term benefits of adding the immunotherapy Imfinzi to chemotherapy for the initial treatment of patients with extensive-stage small-cell lung cancer.

At an average follow-up of about 2 years (25.1 months), the average survival was 12.9 months in patients who received Imfinzi immunotherapy combined with etoposide chemotherapy plus chemotherapy with cisplatin or carboplatin (the experimental group) compared with 10.5 months for patients who received chemotherapy alone (the control group), which translated to a 25% improvement in survival.

“Survival at 2 years improves from 14% [of patients] in the control arm to 22% in the experimental arm. The magnitude of the benefit was similar and very consistent across all the prespecified subgroups of patients analyzed, including those treated with cisplatin or those patients with liver or brain metastases,” Dr. Paz-Ares said.

The CASPIAN study included 805 patients with extensive-stage small-cell lung cancer, including patients who had brain or liver metastases (cancer spreading to the brain or liver). The patients were divided into 1 of the 3 treatment groups, using different chemotherapy regimens, with and without immunotherapy. The study evaluated the impact of adding immunotherapy to chemotherapy compared with chemotherapy alone, using different combinations.

The overall survival was not significantly different based on the type of chemotherapy that was used with the immunotherapy, but rather based on the addition of the immunotherapy to the currently used chemotherapy.

“These data reinforce durvalumab [Imfinzi] plus chemotherapy as an important new standard of care for extensive-stage small-cell lung cancer patients, and this regimen offers patients convenient dosing every 4 weeks during maintenance,” said José Baselga, MD, PhD, Executive Vice-President of Research & Development Oncology with AstraZeneca, the manufacturer of this immunotherapy.

Side Effects

The safety was consistent with the known side effects associated with the drugs used in each treatment regimen, including the immunotherapy and the different chemotherapies.

The most common side effects with Imfinzi immunotherapy in patients with extensive-stage small-cell lung cancer were nausea, fatigue or asthenia, and hair loss.

Side effects leading to treatment discontinuation occurred in 10.2% of patients who received immunotherapy combined with etoposide chemotherapy plus cisplatin or carboplatin chemotherapy compared with 9.4% in those who received chemotherapy alone. In addition, 6 deaths occurred in the immunotherapy plus chemotherapy group compared with 2 in the chemotherapy group alone.

Key Points

  • About 15% of lung cancers are small-cell lung cancer, and about 33% of them are extensive-stage small-cell lung cancer
  • In March 2020, the FDA approved the first immunotherapy, Imfinzi, in combination with chemotherapy, as first-line treatment for patients with extensive-stage small-cell lung cancer
  • This immunotherapy plus chemotherapy combination has been shown as effective first-line treatment for patients with this type of lung cancer
  • The clinical trial that led to the FDA approval of this combination showed that adding immunotherapy to chemotherapy increased the number of patients who survive more than 5 years
  • Before the approval of this combination, the average overall survival for patients with this type of small-cell lung cancer was 10 months

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Last modified: October 16, 2020

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