Market Reacts to New Data from Mirati's Lumakras Competitor and More Trial News
Companies with candidate treatments for cancer in their pipelines posted research outcomes a week before they are set to present at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3-7. Reactions to these data were mixed.
Mirati's Adagrasib Shows Strong Potential Versus NSCLC
Mirati Therapeutics' adagrasib is going up against Amgen’s Lumakras in the KRAS race, and according to Friday pre-market trading, the results shared Thursday don't seem to be enough for investors.
Mirati shared data from the Phase II KRYSTAL-1 study of adagrasib for patients diagnosed with non-small cell lung cancer harboring the KRAS G12C mutation who have received at least one systemic therapy. Some 116 participants were evaluated in October 2021, of whom 98% received prior PD-1/L1 inhibitor treatment in combination with or following chemotherapy.
Initial results after a median follow-up period of 12.9 months showed an objective response rate of 43%, disease control rate of 80%, a median duration of response of 8.5 months and median progression-free survival of 6.5 months. When the same group was assessed in January 2022, the median overall survival was 12.6 months.
Mirati also evaluated the Phase I/IB NSCLC cohort that used 600 mg adagrasib twice a day. In October 2021, the group delivered an ORR of 44% and a disease control rate of 81%. By the January 2022 data cutoff, the median OS was 14.1 months.
"Mirati is at the forefront of KRAS research, and we are pleased with the meaningfully positive clinical outcomes patients are experiencing with adagrasib, both in previously treated lung cancer and in other tumor settings," commented Charles M Baum, MD, Ph.D., the president, founder and R&D head at Mirati.
Stifel analysts painted a brighter picture than the stock numbers show, however, writing that the readout "more or less confirms the similarity of full dose Lumakras and adagrasib monotherapy."
The U.S. Food and Drug Administration (FDA) is currently reviewing adagrasib's New Drug Application for Accelerated Approval. The drug has an ongoing Phase III confirmatory study versus docetaxel for patients with previously treated metastatic NSCLC with a KRAS G12C mutation.
Gracell's RRMM Candidate Delivers Near Perfect Response Rates
Gracell Biotechnologies revealed updates to its current study of GC012F, which is begin assessed for patients with relapsed/refractory multiple myeloma.
The results were based on a trial executive in October 2019 to November 2021, where 28 RRMM patients were enrolled to receive a single infusion of GC012F at three dosage levels: 1x1,000,000 cells/kg (DL1), 2x1,000,000 cells/kg (DL2), and 3x1,000,000 cells/kg (DL3). As of the January 26, 2022 data cutoff, the response rate was 100% at different dose levels in DL1, 80% for the same in DL2 and 93.8% in DL3.
The drug's safety profile also remained consistent with previous studies.
"GC012F is the first dual-targeting CAR-T with clinical data in RRMM, which is designed to improve depth of response as well as tackling some of the major challenges of CAR-T therapy, including the need for faster delivery to the patients in need. We have followed patients for over two and a half years and also enrolled new patients into the study. RRMM still remains an area of unmet medical need, including the need of deepening responses for eligible patients," said Dr. Martina Sersch, chief medical officer at Gracell, in a statement.
The trial is still ongoing and patients are being monitored for the duration of response and best overall response. Aside from ASCO, full details of the study will be shared at the European Hematology Association 2022 Hybrid Congress.
SpringWorks' Slow Progress in Multiple Myeloma
SpringWorks shares dropped 33% on the NASDAQ Friday after data from the company's current evaluation of a proposed drug for relapsed/refractory multiple myeloma indicated some degree of adverse events.
As of the March 4, 2022 data cutoff for its ongoing sub-study of GSK's DREAMM-5 platform trial on low-dose BLENREP plus nirogacestat, one in 14 patients were observed with Grade 3 ocular AEs. Of the group that received BLENREP alone, seven out of 14 patients reported the same AEs. In addition, data expected from the cohort extension arms were not yet mature with the median duration of follow-up at 12 weeks.
"We are encouraged by the emerging clinical profile of nirogacestat with low-dose BLENREP given the promising efficacy and safety profile that we have seen to date, and we look forward to the maturation of the Phase 2 portion of the study in parallel with the initiation of new sub-studies to evaluate this combination with standard of care treatments in multiple myeloma," noted Saqib Islam, the CEO of SpringWorks.
The company will present details at ASCO on June 5.