ASCO 25: Jazz, PharmaMar reveal SCLC survival data News

 Jazz Pharma and PharmaMar have revealed the overall survival (OS) data for their chemotherapy drug Zepzelca in extensive-stage small cell lung cancer (ES-SCLC), showing its potential to improve on immunotherapy when used as a maintenance therapy.

Results released ahead of the ASCO congress, which starts later this week, show that the combination of the DNA-disrupting alkylating agent with Roche's PD-L1 inhibitor Tecentriq (atezolizumab) doubled progression-free survival (PFS) to 5.4 months compared to 2.1 months for Tecentriq alone in the IMforte trial.

There was also a 24.5% improvement in median OS, coming in at 13.2 months with the combination versus 10.6%, respectively, which lead investigator Luis Paz Ares of Octubre University Hospital in Madrid, Spain, said was "a major milestone and could provide a much-needed option for advancing the treatment of this aggressive disease."

IMforte included 483 reasonably fit patients with previously untreated ES-SCLC, and no history of metastases to the brain or spinal cord, comparing Zepzelca (lurbinectedin) plus Tecentriq to Tecentriq on its own as maintenance therapy after standard-of-care induction treatment with Tecentriq and chemotherapy.

Tecentriq is credited with transforming the treatment of ES-SCLC when it was approved as a first-line treatment in 2019, and was joined in that setting the following year by AstraZeneca's PD-L1 inhibitor Imfinzi (durvalumab). Still, despite the use of these cancer immunotherapies, the long-term prognosis for people with the disease remains poor.

Jazz and PharmaMar have already submitted Zepzelca for FDA approval as a first-line maintenance therapy for ES-SCLC on the strength of the IMforte trial, hoping to extend its label beyond the current use as a second-line option after treatment progression with platinum-based induction chemotherapy.

Sales in its initial indication have been hit by competition in the second-line ES-SCLC category, with Jazz reporting a 16% decline in the first quarter of this year to $63 million, so approval in the first-line maintenance indication could help reinvigorate growth.

While there had been some hope that the OS improvement would have been stronger given the gains in PFS, leaving room for future advances, there is no doubt that the results should be strong enough to lead to FDA approval.

SCLC is the most aggressive form of any lung cancer, accounting for around 15% of all cases, and is characterised by rapid progression and poor survival. About 70% of people are diagnosed when SCLC has already spread beyond its original site.

"The integration of lurbinectedin…into the maintenance setting alongside atezolizumab following initial chemo-immunotherapy represents an important next step," said ASCO commentator Charu Aggarwal of the University of Pennsylvania's Abramson Cancer Center.

"This approach offers a way to extend disease control and may signal a shift toward more durable benefit for patients."

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