Bristol Myers Squibb & Co BMY announced on Saturday (June 1) results from the Phase 3 KRYSTAL-12 study evaluating Krazati (adagrasib) compared to standard-of-care chemotherapy for locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) which previously received platinum-based chemotherapy, concurrently or sequentially with anti-PD-(L)1 therapy.
At a median follow-up of 9.4 months, Krazati demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the study’s primary endpoint, compared to docetaxel.
Median PFS was 5.5 months for Krazati compared to 3.8 months for docetaxel.
The overall response rate was also significantly higher with Krazati compared to docetaxel (32% vs. 9%).
The median duration of response (mDOR) was 8.31 months versus 5.36 months (95% CI, 2.86–8.54), respectively.
Krazati demonstrated intracranial response among patients with central nervous system (CNS) metastases at baseline, with a response rate more than double that observed with docetaxel (24% with Krazati vs. 11% with docetaxel).
The KRYSTAL-12 study remains ongoing to assess the additional key secondary endpoint of overall survival.
No new safety signals were identified for KRAZATI, and the safety data were consistent with the known safety profile.
On Monday, Bristol Myers announced results from three updated analyses from the CheckMate -77T, CheckMate -816, and CheckMate -9LA studies supporting Opdivo (nivolumab) and Opdivo-based combinations in early-stage and advanced NSCLC.
CheckMate -77T study of perioperative Opdivo shows improved event-free survival and pathologic complete response in stage III resectable NSCLC patients regardless of nodal status.
Four-year follow-up data from the CheckMate -816 study reinforce neoadjuvant Opdivo plus chemotherapy in patients with resectable NSCLC.
Five-year follow-up data from the CheckMate -9LA study showed Opdivo plus Yervoy and chemotherapy improves survival in patients with previously untreated metastatic NSCLC versus chemotherapy alone.
At ASCO, Bristol Myers Squibb announced data from three studies evaluating Breyanzi (lisocabtagene maraleucel; liso-cel).
Long-term data with three-year follow-up from the Phase 3 TRANSFORM trial in patients with relapsed or refractory large B-cell lymphoma (LBCL) showed ongoing event-free survival and durable responses with Breyanzi compared to standard of care.
The MCL cohort of TRANSCEND NHL 001 enrolled adults with relapsed or refractory disease. In a subgroup analysis, Breyanzi showed similar efficacy across most subgroups based on overall responses, complete responses, median duration of response, progression-free survival, and overall survival, including in heavily pretreated patients.
BMY Price Action: Bristol Myers Squibb shares are up 1.75% at $41.81 at last check Monday.
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