Trial results for the SAVANNAH study (NCT03778229), investigating osimertinib in combination with savolitinib for patients with EGFRm+ and MET+ locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed following prior osimertinib treatment, were posted on ClinicalTrials.gov on 2026-02-10. The combination of savolitinib 300 mg BID and osimertinib demonstrated an Objective Response Rate (ORR) of 56.3% by investigator assessment in the target population.
Background
The SAVANNAH study (NCT03778229) was designed to investigate the efficacy of osimertinib in combination with savolitinib. This combination therapy targets patients with EGFRm+ and MET+ locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression after prior treatment with osimertinib.
Trial design
The SAVANNAH study (NCT03778229) is a Phase 2 trial with an enrollment of 367 participants. The study focuses on patients with Carcinoma, specifically those with EGFRm+ and MET+ locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib. Interventions included osimertinib, savolitinib, and placebo. The study investigated the efficacy of osimertinib in combination with savolitinib.
Key results
The trial results provided several key measurements for the combination of osimertinib and savolitinib in the target patient population:
- Objective Response Rate (ORR) by Investigator Assessment: For the Savo 300 mg BID + Osi group, the ORR was 56.3% (Percent of subjects).
- Objective Response Rate (ORR) by BICR Assessment: For the Savo 300 mg BID + Osi group, the ORR was 55.0% (Percent of subjects).
- Objective Response Rate (ORR) by Investigator Assessment: For the Savo 300 mg QD + Osi group, the ORR was 31.6% (Percent of subjects).
Further analysis on the contribution of components showed:
- Objective Response Rate (ORR) by Investigator Assessment: Savo 300 mg BID + Osi achieved 54.2%, while Savo 300 mg BID Monotherapy achieved 24.0% (Percent of subjects).
- Objective Response Rate (ORR) by BICR Assessment: Savo 300 mg BID + Osi achieved 58.3%, while Savo 300 mg BID Monotherapy achieved 16.0% (Percent of subjects).
Other key efficacy outcomes for the Savo 300 mg BID + Osi group included:
- Duration of Response (DoR) by Investigator Assessment: Median of 7.13 months.
- Duration of Response (DoR) by BICR Assessment: Median of 9.92 months.
- Progression-free Survival (PFS) by Investigator Assessment: Median of 7.39 months.
- Progression-free Survival (PFS) by BICR Assessment: Median of 7.52 months.
- Overall Survival (OS): Median of 14.42 months.
What this means
The results from the SAVANNAH study indicate that the combination of osimertinib and savolitinib may offer a meaningful clinical benefit for patients with EGFRm+ and MET+ NSCLC who have progressed after prior osimertinib treatment. The observed Objective Response Rates, particularly with the savolitinib 300 mg BID dose, alongside median Duration of Response, Progression-free Survival, and Overall Survival, suggest this regimen could be an important therapeutic option for a patient population with limited treatment alternatives after progression on osimertinib monotherapy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03778229, titled "Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib," were posted on 2026-02-10 on clinicaltrials.gov.