FDA grants Alecensa accelerated approval for people with a specific type of lung cancer

Roche announced that the US Food and Drug Administration (FDA) granted accelerated approval to Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. In the pivotal studies, Alecensa shrank tumours in up to 44 percent of people with ALK-positive NSCLC who progressed on crizotinib (objective response rate [ORR] of 38 percent [95 percent CI 28-49] and 44 percent [95 percent CI 36-53])

Possible serious side effects with Alecensa include liver problems, lung problems, slow heartbeat, muscle pain, tenderness and weakness. The most common side effects of Alecensa include tiredness, constipation and swelling in the hands, feet, ankles and eyelids.

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit. The indication for Alecensa is approved under accelerated approval based on tumour response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Chugai Launches of the ALK Inhibitor Alecensa

Chugai Pharmaceutical Co., Ltd. announced that it obtained approval from the Ministry of Health, Labour and Welfare on September 2, 2015 for “Alecensa^® Capsule 150mg,” a high content preparation of the ALK inhibitor “Alecensa^® Capsule 20mg and 40mg” (generic name: alectinib hydrochloride) sold for the indication of "ALK fusion gene positive unresectable, advanced/recurrent non-small cell lung cancer." Following its National Health Insurance Drug Price listing on November 28, we launch the “Alecensa^® Capsule 150mg” today.

 

Regarding Alecensa, the patients have been obliged to orally take in total of 8 capsules (7 capsules of 40mg preparation and 1 capsule of 20mg preparation) per time, twice daily. Considering great need of a high content preparation to improve convenience of patients, Chugai started developing a 150mg preparation and filed an application in September 2014.

TAGRISSO approved by the US FDA

AstraZeneca announced that the US Food and Drug Administration (FDA) has approved TAGRISSO™ (AZD9291) 80mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

AZD9291 is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer. This indication is approved under the FDA’s accelerated approval process based on tumour response rate and duration of response (DoR).

AZD9291 is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the activating, sensitising mutations (EGFRm), and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance. Nearly two-thirds of NSCLC patients who are EGFR mutation-positive and experience disease progression after being treated with an EGFR-TKI develop the T790M resistance mutation, for which there have been limited treatment options.

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths, more than breast, prostate and colorectal cancers combined. Lung cancer has a five-year survival rate that is less than 20%. Approximately 85% of all lung cancers in the US are NSCLC; 10% to 15% of these are EGFR mutation-positive. Approximately two-thirds of patients treated with EGFR TKI therapy will acquire resistance related to the T790M mutation

Boehringer Ingelheim initiates efficacy and safety of BI 1482694

Boehringer Ingelheim announced at the BIO-Europe® conference in Munich, Germany, the initiation of a global Phase II trial evaluating the efficacy and safety of BI 1482694 (HM61713) in patients with T790M mutation-positive non-small cell lung cancer (NSCLC), whose tumours stopped responding to currently available epidermal growth factor receptor (EGFR) directed therapies. The primary endpoint of this trial, which is the first in a broad clinical development programme for BI 1482694, is objective response rate (ORR). 

BI 1482694 is a novel, third-generation, oral, irreversible EGFR mutant-specific tyrosine kinase inhibitor (TKI) developed to specifically target tumours with T790M mutations. At this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, interim results of the Phase I/II clinical trial indicated strong efficacy signals in patients with such tumours, combined with a favourable safety profile.¹ The T790M mutation is known as the most common resistance mechanism to develop in response to treatment with EGFR TKIs. It is found in approximately 50-60% of patients who previously received EGFR TKI therapy. There are currently no EGFR-directed therapies approved specifically for the treatment of this mutation, representing an area of great unmet need for these patients. 

AstraZeneca Presents Evidence of AZD9291 in Non-Small Cell Lung Cancer

AstraZeneca today announced updated, encouraging data on AZD9291 (osimertinib) in first-line patients with epidermal growth factor receptor mutation (EGFRm) positive advanced non-small cell lung cancer (NSCLC) and previously treated patients with EGFR T790M mutation-positive NSCLC. The data being presented today at the World Conference on Lung Cancer (WCLC) 2015 were from the AURA Phase I trial first-line cohort and two AURA Phase II studies. 

 

Data in the first-line setting demonstrated that in 60 patients who received AZD9291 once daily 72% (95% confidence interval (CI) 58% to 82%) were progression free (PFS) at 12 months. Confirmed overall response rate (ORR) was 75% (95% CI 62% to 85%). The longest duration of response (DoR) was ongoing at 18 months.

Data on two AURA Phase II studies (AURA extension and AURA2) in previously treated patients with EGFR T790M mutation were also presented. While still preliminary, these studies showed an efficacy and tolerability profile for AZD9291 consistent with previously reported data. In AURA extension (n=201), ORR was 61% (95% CI 54% to 68%); median DoR and median PFS were not calculable (NC). Consistent results were observed in AURA2 (n=210), ORR was 71% (95% CI 64% to 77%); median DoR was 7.8 months (95% CI 7.1 months to NC) and median PFS was 8.6 months (95% CI 8.3 months to 9.7 months).

The safety profile of AZD9291 in these studies was in line with that reported earlier in the year. In the AURA first-line cohort, the most common all-cause adverse events (AE) of any grade across different dose groups included rash (grouped terms) (77% all grades, 2% Grade greater-than or equal to 3) and diarrhea (73% all grades, 3% Grade greater-than or equal to 3). These AEs were also reported as the most common in the two AURA Phase II studies (AURA extension, rash 40% all grades, 1% Grade greater-than or equal to 3, diarrhea 45% all grades, 1% Grade greater-than or equal to 3; AURA 2, rash 42% all grades, 1% Grade greater-than or equal to 3, diarrhea 39% all grades, 1% Grade greater-than or equal to 3).