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Mirati (MRTX) Up on Positive Data From NSCLC Study on Adagrasib
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Shares of Mirati Therapeutics, Inc. were up 36.45% on Jun 7 after the company announced positive results from an early stage KRYSTAL-1 study on investigational candidate adagrasib for lung cancer.
The KRYSTAL study is evaluating intracranial (IC) responses of adagrasib in patients with KRASG12C-mutated non-small cell lung cancer (NSCLC) with active and untreated central nervous system (CNS) metastases.
In the study, 25 patients with active, untreated CNS metastases were enrolled and treated with adagrasib 600 mg BID with a median follow-up of 6.6 months (data cutoff date December 2021).
Results of a prospective analysis from the phase Ib cohort of the KRYSTAL-1 study showed that one-third of the patients had an IC response in patients with CNS metastases, consistent with what was observed systemically in this cohort.
Of the radiographically evaluable patients (n=19), results showed an IC objective response rate of 32% by modified response assessment in neuro-oncology-brain metastases by blinded independent central review.
Three patients achieved a complete response and three achieved a partial response in this analysis. The IC disease control rate was 84% (16/19, including 10 patients with stable disease). The median IC duration of response was not reached.
Per the company, CNS metastases occur in 27% to 42% of patients with KRASG12C mutated NSCLC at diagnosis. CNS metastases disproportionately affect patients with NSCLC and should be carefully considered as part of the treatment approach.
With a median follow-up of 6.6 months, these early and positive data show adagrasib demonstrated a meaningful overall intracranial response rate with early indications for overall survival.
The safety profile of adagrasib in this study was consistent with the overall population, with no new safety signals observed.
Investors cheered the news as the positive data demonstrated the candidate’s potential as a treatment option for this underserved patient population.
Mirati also presented results from the registration-enabling phase II cohort of the KRYSTAL-1 study evaluating adagrasib in patients with pre-treated NSCLC harboring a KRASG12C mutation during the Lung Cancer–Non-Small Cell Metastatic session at ASCO on Jun 3, 2022.
Adagrasib is an investigational, highly selective and potent oral small-molecule inhibitor of KRASG12C optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours.
The candidate is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC, colorectal cancer and pancreatic cancer.
The new drug application for adagrasib is currently under review in the United States for the treatment of patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy.
Mirati has plunged 57.3% compared with the industry’s decline of 23.2%.
Image Source: Zacks Investment Research
Upon successful development, adagrasib is likely to give stiff competition to Amgen’s (AMGN - Free Report) Lumakras (sotorasib), a KRASG12C inhibitor as well. Amgen received FDA approval of Lumakras in May 2021 for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
Amgen is also evaluating the drug in multiple other solid tumors.
ALKS’ loss estimates for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed on earnings in all the trailing four quarters, the average being 350.48%.
GERN’s loss estimates for 2022 have narrowed 6 cents in the past 60 days. Geron surpassed on earnings in three of the trailing four quarters and missed the mark in the remaining one, the average surprise being 1.07%.
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Mirati (MRTX) Up on Positive Data From NSCLC Study on Adagrasib
Shares of Mirati Therapeutics, Inc. were up 36.45% on Jun 7 after the company announced positive results from an early stage KRYSTAL-1 study on investigational candidate adagrasib for lung cancer.
The KRYSTAL study is evaluating intracranial (IC) responses of adagrasib in patients with KRASG12C-mutated non-small cell lung cancer (NSCLC) with active and untreated central nervous system (CNS) metastases.
In the study, 25 patients with active, untreated CNS metastases were enrolled and treated with adagrasib 600 mg BID with a median follow-up of 6.6 months (data cutoff date December 2021).
Results of a prospective analysis from the phase Ib cohort of the KRYSTAL-1 study showed that one-third of the patients had an IC response in patients with CNS metastases, consistent with what was observed systemically in this cohort.
Of the radiographically evaluable patients (n=19), results showed an IC objective response rate of 32% by modified response assessment in neuro-oncology-brain metastases by blinded independent central review.
Three patients achieved a complete response and three achieved a partial response in this analysis. The IC disease control rate was 84% (16/19, including 10 patients with stable disease). The median IC duration of response was not reached.
Per the company, CNS metastases occur in 27% to 42% of patients with KRASG12C mutated NSCLC at diagnosis. CNS metastases disproportionately affect patients with NSCLC and should be carefully considered as part of the treatment approach.
With a median follow-up of 6.6 months, these early and positive data show adagrasib demonstrated a meaningful overall intracranial response rate with early indications for overall survival.
The safety profile of adagrasib in this study was consistent with the overall population, with no new safety signals observed.
Investors cheered the news as the positive data demonstrated the candidate’s potential as a treatment option for this underserved patient population.
Mirati also presented results from the registration-enabling phase II cohort of the KRYSTAL-1 study evaluating adagrasib in patients with pre-treated NSCLC harboring a KRASG12C mutation during the Lung Cancer–Non-Small Cell Metastatic session at ASCO on Jun 3, 2022.
Adagrasib is an investigational, highly selective and potent oral small-molecule inhibitor of KRASG12C optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours.
The candidate is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC, colorectal cancer and pancreatic cancer.
The new drug application for adagrasib is currently under review in the United States for the treatment of patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy.
Mirati has plunged 57.3% compared with the industry’s decline of 23.2%.
Image Source: Zacks Investment Research
Upon successful development, adagrasib is likely to give stiff competition to Amgen’s (AMGN - Free Report) Lumakras (sotorasib), a KRASG12C inhibitor as well. Amgen received FDA approval of Lumakras in May 2021 for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
Amgen is also evaluating the drug in multiple other solid tumors.
Mirati currently has a Zacks Rank #3 (Hold).
A few better-ranked stocks are Alkermes (ALKS - Free Report) and Geron Corporation (GERN - Free Report) . While Alkermes sports a Zacks Rank #1 (Strong Buy), Geron has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
ALKS’ loss estimates for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed on earnings in all the trailing four quarters, the average being 350.48%.
GERN’s loss estimates for 2022 have narrowed 6 cents in the past 60 days. Geron surpassed on earnings in three of the trailing four quarters and missed the mark in the remaining one, the average surprise being 1.07%.