Small cell lung cancer (SCLC) is an aggressive malignancy that often responds well to initial treatment but frequently relapses. Researchers are actively exploring new therapeutic strategies, including targeted therapies and immunotherapies, to improve outcomes for patients with this challenging disease.
Recent FDA Approvals
The FDA has recently approved several treatments for SCLC, offering new options for patients at different stages of the disease.
Imdelltra (tarlatamab-dlle): In May 2023, the FDA granted accelerated approval to Imdelltra for extensive-stage SCLC. This immunotherapy drug is administered via injection weekly for the first three doses, then bi-weekly thereafter. Clinical trials demonstrated a 44% objective response rate (complete or partial shrinkage of tumors) in 99 patients with relapsed or refractory extensive-stage SCLC. Notably, 40% of responders experienced tumor shrinkage lasting over a year.
Trilaciclib (Cosela): Approved in February 2021, trilaciclib helps reduce chemotherapy-induced myelosuppression in patients with extensive-stage SCLC. Myelosuppression, a condition where bone marrow cells fail to produce adequate blood cells, can limit the intensity of chemotherapy regimens. By mitigating this side effect, trilaciclib potentially allows for higher chemotherapy doses, potentially improving cancer cell destruction and survival.
Durvalumab (Imfinzi): In March 2020, the FDA approved durvalumab, an immunotherapy drug, in combination with etoposide and either carboplatin or cisplatin as a first-line treatment for extensive-stage SCLC. Clinical trial data showed that the median overall survival for patients receiving durvalumab plus chemotherapy was 13 months, compared to 10.3 months for those receiving chemotherapy alone.
Lurbinectedin (Zepzelca): Lurbinectedin received accelerated approval in June 2020 for patients with metastatic SCLC. Clinical trials reported an overall response rate of 35% with lurbinectedin, with a median duration of response exceeding 5.3 months.
Investigational Therapies in Clinical Trials
Several promising therapies are currently under investigation in clinical trials for SCLC.
Ivonescimab: This targeted therapy is being evaluated in combination with cadonilimab for extensive-stage SCLC in a Phase 2 clinical trial (NCT06620796), with expected completion by 2027.
PM8002: As a second-line treatment for SCLC, PM8002, an immunotherapy drug, is being investigated in conjunction with paclitaxel versus chemotherapy alone in a Phase 3 trial (NCT06616532), anticipated to conclude by 2028.
Adebelimab: Researchers are assessing adebelimab, a targeted therapy, combined with chemotherapy as a first-line treatment for extensive-stage SCLC. Phase 2 (NCT06614621) and Phase 3 (NCT06610734) clinical trials are underway, with expected completion by 2028. The Phase 3 trial also explores the addition of low-dose radiation therapy to adebrelimab and chemotherapy.
IBI3009: A Phase 1 clinical trial (NCT06613009) is examining the efficacy of IBI3009, a targeted therapy, in patients with locally advanced or metastatic SCLC that is not amenable to surgical resection. The trial is expected to be completed by 2027.
YL201: The effectiveness and safety of YL201, a targeted therapy, in combination with topotecan hydrochloride, is being evaluated in a Phase 3 clinical trial (NCT06612151) for patients with relapsed SCLC. The study is projected to be completed by 2030.
ZG006: A Phase 1 clinical trial (NCT06592638) is assessing the safety, effectiveness, and tolerability of ZG006, an immunotherapy drug, for treating SCLC that is refractory to or ineligible for standard treatment. The trial is expected to be completed in 2027.
Tarlatamb: A Phase 1 clinical trial (NCT06598306) is investigating the effectiveness of tarlatamb, an immunotherapy drug, for treating extensive-stage SCLC. The trial is expected to be completed in 2028.
