Jacob Sands, MD, physician, Dana-Farber Cancer Institute, instructor in medicine, Harvard Medical School, discusses the FDA approval of lurbinectedin (Zepzelca) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression, following platinum-based chemotherapy.

The agent was approved under the FDA's “Accelerated Approval” Program, which allows for the conditional approval of a therapy that fills an unmet need for a serious or life-threatening disease or condition. The regulatory decision is based on data from a phase 2 basket trial (NCT2454972) of 105 patients with SCLC who progressed on platinum-containing therapy.

Results from the trial showed that the agent led to an overall response rate (ORR) of 35.2%. Additionally, the disease control rate was 68.6% (95% CI, 58.8%-77.3%). It has been difficult to develop an effective and tolerable second-line therapy for patients with resistant and rapidly progressive SCLC, explains Sands. The approval of lurbinectedin has helped to close this area of unmet need, concludes Sands.

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Jacob Sands, MD, discusses the FDA approval of lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer with disease progression, following platinum-based chemotherapy. 

Dr. Sands on the FDA Approval of Lurbinectedin in Small Cell Lung Cancer

Jacob Sands, MD, physician, Dana-Farber Cancer Institute, instructor in medicine, Harvard Medical School, discusses the rationale to explore DS-1062 in advanced non—small cell lung cancer (NSCLC).

At the 2019 ASCO Annual Meeting, Sands presented the safety and preliminary antitumor activity of DS-1062 in patients with advanced NSCLC. DS-1062 is a Trop-2-targeted antibody-drug conjugate (ADC). Trop-2 is a protein that is commonly seen on the surface of cancer cells. By targeting Trop-2 with an ADC, treatment can be delivered with less toxicity and more potency, explains Sands.

As a phase I dose-escalation trial, patients were started on relatively low doses of the drug. Among the 35 evaluable patients who received DS-1062, the dose levels ranged from 0.27 mg/kg to 8.0 mg/kg every 21 days. A total of 10 partial responses have been reported so far. These patients received a median of 3.5 prior lines of therapy, including prior EGFR or ALK inhibitors and checkpoint inhibitors. 

Notably, patients were escalated beyond what researchers anticipated would be the maximum-tolerated dose, with a tolerability profile that has been consistent across doses, says Sands. However, higher response rates have been seen with higher doses of the drug. These data are very encouraging in a setting of high unmet need, Sands concludes. 

Jacob Sands, MD, physician, Dana-Farber Cancer Institute, instructor in medicine, Harvard Medical School, discusses the rationale to explore DS-1062 in advanced non–small cell lung cancer (NSCLC).

Jacob Sands, MD

Articles

Dr. Sands on the FDA Approval of Lurbinectedin in Small Cell Lung Cancer

Dr. Sands on the Rationale to Explore DS-1062 in Advanced NSCLC