MAGELLAN arms B1 and B3: Durvalumab plus chemotherapy with and without oleclumab in treatment-naïve metastatic non-small-cell lung cancer
Bibliographic record
Abstract
OBJECTIVES: Standard-of-care therapies for metastatic non-small-cell lung cancer (mNSCLC) have mixed outcomes that remain unsatisfactory. Durvalumab (anti-PD-L1) plus oleclumab (anti-CD73) might provide a synergistic antitumor effect by antagonizing separate immune pathways. We report safety, efficacy, pharmacokinetics, and immunogenicity findings of durvalumab + chemotherapy ± oleclumab as first-line treatment of mNSCLC from Arms B1 and B3 in the phase 1B MAGELLAN (NCT03819465) study. METHODS: In Cohort B, treatment-naïve adults with histologically/cytologically confirmed mNSCLC and PD-L1 expression on < 50 % tumor cells were eligible. Patients received investigator's choice of chemotherapy plus 1500 mg durvalumab three-weekly (Q3W) for four cycles and durvalumab Q4W thereafter in Arm B1, with addition of 2250 mg oleclumab Q3W for four cycles and 3000 mg Q4W thereafter in Arm B3. Primary endpoint was safety and tolerability; key secondary endpoint was efficacy by investigator-assessed objective response rate (ORR; RECIST v1.1). RESULTS: Patient demographics and disease characteristics were generally consistent between arms. All but one patient experienced treatment-emergent adverse events (AEs). Grade 3 or 4 AEs and AEs leading to discontinuation occurred in 14/33 (42.4 %) and 3/33 (9.1 %) patients in Arm B1 and 18/32 (56.3 %) and 6/32 (18.8 %) patients in Arm B3. No treatment-related deaths occurred in Arm B1; one (3.1 %) fatal AE of unknown cause was deemed possibly related to both durvalumab and oleclumab by the investigator in Arm B3. ORR was 36.4 % (95 % CI, 20.4-54.9) and 21.9 % (95 % CI, 9.3-40.0) in Arms B1 and B3, respectively - all partial responses. Median duration of response was 11.8 months (95 % CI, 3.2-26.6) and 8.8 months (95 % CI, 2.3-not calculable), respectively. CONCLUSION: No new safety signals were identified for durvalumab + chemotherapy ± oleclumab in patients with mNSCLC and PD-L1 expression < 50 %. The lack of meaningful efficacy improvements limits potential further development of this combination in this disease setting.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".