Novartis announced updated results from the landmark COMBI-AD clinical trial, demonstrating that treatment with Tafinlar® (dabrafenib) and Mekinist® (trametinib) following the surgical removal of melanoma offers a long-term and durable relapse-free survival (RFS) benefit to high-risk patients diagnosed with stage III, BRAF-mutation positive melanoma1. Researchers reported that 52% (95% CI, 48%-58%) of patients treated with adjuvant Tafinlar + Mekinist were alive and relapse-free at five years.
Among patients in the study’s placebo arm 36% (95% CI, 32%-41%) were alive and relapse-free at the time of this analysis, generally consistent with typical melanoma relapse-free survival rates seen among patients with resected stage III disease without treatment. Consistent RFS benefit was observed across all AJCC 7 stage III subgroups.
Median RFS, or the length of time when 50% of patients are still alive and relapse-free, was not yet reached at the 5-year data cut-off for patients on Tafinlar + Mekinist treatment, suggesting long-term benefit of targeted therapy in the adjuvant (post-surgical) setting (NR; 95% CI, 47.9 mo-NR). Median RFS was 16.6 months for patients taking a placebo (95% CI, 12.7-22.1 mo). Treatment with Tafinlar + Mekinist reduced the risk of relapse or death by 49% compared to placebo (hazard ratio [HR] 0.51; 95% CI 0.42, 0.61)1.
“Our goal as clinicians is to give our stage III patients the best chance for relapse-free survival,” said Prof. Axel Hauschild, MD, Professor of Dermatology, University Hospital Schleswig-Holstein, Germany. “Results from COMBI-AD show that adjuvant treatment with Tafinlar + Mekinist after surgical resection gives melanoma patients the chance for long-term relapse-free survival. Five years is a clinically and emotionally significant milestone for patients. Recurrent BRAF+ melanoma, once spread to other organs, can be more dangerous and difficult to treat. The durable, long-term results seen among patients in the COMBI-AD trial clearly point to the important role targeted therapy plays in the adjuvant setting.”
The COMBI-AD study results are drawn from a prospective analysis of 870 patients with BRAF V600-mutated melanoma treated with Tafinlar + Mekinist after their surgery. This study represents the largest collection of data and longest follow-up to date in this patient population treated with targeted therapy2. The findings were presented at the ASCO20 Virtual Scientific Program (Abstract #10001).
“The five-year survival mark is an important and predictive milestone for people with melanoma and the doctors who care for them,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “We see an almost 50% risk reduction in melanoma relapse or death in the COMBI-AD data announced today, and we believe patients will find this information helpful in choosing a treatment after surgery. We thank the patients and their families who participated in this long-term clinical trial. Their participation and commitment is helping the community learn how a BRAF-targeted therapy can reimagine outcomes for patients with resectable stage III melanoma.”
AstraZeneca is advancing its ongoing response to address the unprecedented challenges of COVID-19, collaborating with a number of countries and multilateral organisations to make the University of Oxford’s vaccine widely accessible around the world in an equitable manner.
The Company has concluded the first agreements for at least 400 million doses and has secured total manufacturing capacity for one billion doses so far and will begin first deliveries in September 2020. AstraZeneca aims to conclude further agreements supported by several parallel supply chains, which will expand capacity further over the next months to ensure the delivery of a globally accessible vaccine.
AstraZeneca received support of more than $1bn from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of the vaccine, starting in the fall. The development programme includes a Phase III clinical trial with 30,000 participants and a paediatric trial.
In addition, the Company is engaging with international organisations such as the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organisation (WHO), for the fair allocation and distribution of the vaccine around the world. AstraZeneca is also in discussions with governments around the world to increase access. Furthermore, AstraZeneca is in discussions with the Serum Institute of India and other potential partners to increase production and distribution.
AstraZeneca recently joined forces with the UK Government to support Oxford University’s vaccine and has progressed rapidly in its efforts to expand access around the world. The Company will supply the UK starting in September and is thankful for the Government’s commitment and overall work on vaccines.
Pascal Soriot, Chief Executive Officer, said: “This pandemic is a global tragedy and it is a challenge for all of humanity. We need to defeat the virus together or it will continue to inflict huge personal suffering and leave long-lasting economic and social scars in every country around the world. We are so proud to be collaborating with Oxford University to turn their ground-breaking work into a medicine that can be produced on a global scale. We would like to thank the US and UK governments for their substantial support to accelerate the development and production of the vaccine. We will do everything in our power to make this vaccine quickly and widely available.”
AstraZeneca has now finalised its licence agreement with Oxford University for the recombinant adenovirus vaccine. The licensing of the vaccine, formerly ChAdOx1 nCoV-19 and now known as AZD1222, follows the recent global development and distribution agreement with the University’s Jenner Institute and the Oxford Vaccine Group. AstraZeneca has also agreed to support the establishment of a joint research centre at Oxford University for pandemic preparedness research.
A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. Data from the trial is expected shortly which, if positive, would lead to late-stage trials in a number of countries. AstraZeneca recognises that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk.
The Company’s comprehensive pandemic response also includes rapid mobilisation of AstraZeneca’s global research efforts to discover novel coronavirus-neutralising antibodies to prevent and treat progression of the COVID-19 disease, with the aim of reaching clinical trials in the next three to five months. Additionally, the Company has quickly moved into testing of new and existing medicines to treat the infection, including CALAVI and ACCORD trials underway for Calquence (acalabrutinib) and DARE-19 trial for Farxiga (dapagliflozin) in COVID-19 patients.
Financial considerations
Today’s announcement is not anticipated to have any significant impact on the Company’s financial guidance for 2020; expenses to progress the vaccine are anticipated to be offset by funding by governments.
AZD1222
ChAdOx1 nCoV-19, now known as AZD1222, was developed by Oxford University’s Jenner Institute, working with the Oxford Vaccine Group. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold (adenovirus) virus that causes infections in chimpanzees and contains the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack COVID-19 if it later infects the body.
The recombinant adenovirus vector (ChAdOx1) was chosen to generate a strong immune response from a single dose and it is not replicating, so cannot cause an ongoing infection in the vaccinated individual. Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well tolerated, although they can cause temporary side effects such as a temperature, influenza-like symptoms, headache or a sore arm.
A webinar on ‘Medical Devices and API sector: Challenges & Emerging Opportunities’ was held on 22nd May, 2020 at 11.30 am for business and trade collaboration between India and Japan in the post COVID-19 scenario. The webinar was organized by the Embassy of India, Tokyo in partnership with the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India.
Mr. Sanjay Kumar Verma, Ambassador of India to Japan shared his valuable thoughts on the golden opportunity for India and Japan to further boost their relationship in the context of the ongoing COVID-19 crisis. Dr. P. D. Vaghela, Secretary, Pharmaceuticals presented the sectoral view and the investment opportunities in the pharmaceutical and medical device industry in India. He also presented various initiatives taken by the Government of India to promote trade and business in the country. Mr. Navdeep Rinwa, Joint Secretary, Pharmaceuticals explained the Department’s schemes to promote manufacturing of bulk drugs and medical devices viz. Production Linked Incentive schemes and Promotion of Bulk Drug/Medical Devices Parks and requested the delegates to avail benefits of the schemes.
Pharmaceutical Traders Association and Japan Federation of Medical Devices Associations deliberated on the Post COVID-19 challenges & opportunities for Pharmaceutical & Medical Device sectors and its impact on the global supply chain and suggested that cooperation between the two countries can contribute to stabilize the supply-chain of especially APIs and Medical Devices. Representative of JETRO Chennai also shared insights on challenges and emerging opportunities in API sector and Medical Devices.
?Ms. Mona K C Khandhar, Minister (Economic & Commerce), EoI, Tokyo mentioned about the resilience and strength of the Indian economy and detailed on the stimulus & reform packages announced by the Government of India to address the COVID-19 crisis and to improve the investment environment. The advantages of Indian economy, FDI ecosystem & Japan specific facilitation were also mentioned.
Representatives of Japanese subsidiaries Nipro India Corp and Eisai Pharmaceuticals India Pvt Ltd shared a detailed presentation and their experience about ‘Make in India’ program.
Representatives of major Indian Pharmaceutical and Medical Device Associations presented the future growth opportunities and way forward for Pharmaceutical and Medical Device industry in India.
?Representatives of State Governments of Gujarat, Telangana, Himachal Pradesh and Goa offered finer details of the investment opportunities in their respective States including package for incentives and taxation benefits, ease of doing business initiatives, land availability, infrastructural facilities, regulatory framework and invited Japanese companies for investing in their respective States.
?Representatives of Andhra Pradesh MedTech Zone, Wockhardt, Sun Pharma, Panacea Biotec and other large number of Japanese companies also participated in the webinar as part of G2B and B2B networking.
Biological E. Limited (BE), a Hyderabad-based pharmaceuticals & Biologics company, announced the acquisition of Akorn India Limited, a subsidiary of Akorn Inc., USA.
ICMR has partnered with Bharat Biotech lnternational Limited (BBIL) to fast-track clinical trials of the indigenous COVID-19 vaccine (BBV152 COVID Vaccine) and its clinical trials were approved by DCGI by end of June.
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