Among all solid tumours, small cell lung cancer (SCLC) has proved extremely difficult to treat. Unlike for non-small cell lung cancer (NSCLC), developing therapeutics for SCLC has seldom seen success. SCLC, which is characterised as a high-grade tumour and makes up roughly 15% of global lung cancer cases, remains a challenge from a treatment perspective. A large portion of patients with early disease will experience metastasis (60%) due to its highly aggressive and proliferative nature. Patients with extensive-stage (ES) disease have a poor two-year survival rate of about 7%.

NSCLC has seen some improvements in prognosis and treatment following the introduction of immunotherapeutic agents targeting PD-1 [programmed death cell-1] pathways. These options did not translate into tangible results for SCLC, as the disease is often associated with low PD-L1 expression. The Phase III KEYNOTE-604 trial assessed Merck‘s Keytruda (pembrolizumab) in combination with standard-of-care (SOC) etoposide and platinum-based therapy as front-line treatment for ES SCLC patients (n=453). While the Keytruda combination showed a numerical improvement in overall survival (OS), it did not reach statistical significance (P=0.0164). Similarly, Keytruda’s addition to SOC only marginally improved the objective response rate (ORR). Keytruda and Bristol Myers Squibb’s Opdivo (nivolumab), originally approved in 2019 and 2018 respectively, have since had their SCLC-approved treatment status withdrawn, due to a lack of sustained efficacy in Phase III data.

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Bispecific T-cell engagers (BiTEs) have a successful track record of receiving accelerated US Food and Drug Administration approvals for hard-to-treat blood malignancies such as multiple myeloma. This success has now been carried across to solid malignancies with Amgen’s Imdelltra (tarlatamab-dlle) having received approval for ES SCLC in patients with disease progression on or after platinum-based chemotherapy, such as cisplatin and etoposide, which has dominated the treatment paradigm for decades.

A bridge between ligand 3 and CD3

This approval follows from the successful pivotal Phase II trial DeLLphi-301, which tested Imdelltra in the third line. The results showed a median OS of 14.3 months with an ORR of 40%. Of 69 patients with known platinum-based chemotherapy sensitivity status, the ORR was even higher at 52%. This study demonstrates the clinical benefits of using BiTEs following platinum-based regimens, which still represent a dominant force in the current treatment paradigm. Imdelltra forms a bridge between the death-like ligand 3, overexpressed on SCLC cells, and CD3 on T cells, facilitating an immune response. Cohort analyses further supported Imdelltra’s clinical efficacy by demonstrating T cells’ upregulation in the tumour microenvironment. But despite its strong clinical attributes, Imdelltra has a major drawback in its safety profile, with a current boxed warning associated with its high rate of cytokine release syndrome events, as well as neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome – both of which can cause serious lifelong effects or death.

Imdelltra is expected to make significant headway in the market, with GlobalData’s analyst consensus forecast predicting its global sales to reach $975 million by 2030. This evaluation will likely increase as Imdelltra enters a market that is dominated by chemotherapy with limited immunotherapy options. Currently, Amgen is conducting a Phase III clinical trial evaluating Imdelltra against SOC chemotherapy in relapsed SCLC (DeLLphi-304). Considering all the clinical evidence leading to Imdelltra’s approval for SCLC in May 2024, its dominance in this market is all but assured.

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