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2021-06-15

AstraZeneca has announced a raft of encouraging trial results, a new drug approval and a new key appointment.

A phase III trial has shown AstraZeneca and MSD¨s Lynparza (olaparib) reduced the risk of cancer recurrence by 42 per cent in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer.

Dave Fredrickson, executive vice-president, oncology business unit, AstraZeneca (25544507)Dave Fredrickson, executive vice-president, oncology business unit, AstraZeneca (25544507)Dave Fredrickson, executive vice-president, oncology business unit, AstraZeneca (25544507)

Dave Fredrickson, executive vice president, oncology business unit, said: ^This is the first time that any medicine targeting a BRCA mutation has demonstrated the potential to change the course of early-stage breast cancer and offer hope for a cure.

^By providing a treatment which significantly reduces the risk of breast cancer returning in these high-risk patients, we hope Lynparza will set a new benchmark demonstrating sustained clinical benefit. We are working with regulatory authorities to bring Lynparza to these patients as quickly as possible. ̄

Meanwhile, another phase III trial showed AstraZeneca¨s Imfinzi (durvalumab) encouraging results for patients with unresectable, stage III non-small cell lung cancer (NSCLC) who had not progressed following concurrent chemoradiation therapy (CRT). A third of patients were progression-free at five years – the longest-ever survival reported in a phase III immunotherapy trial in this setting.

An aerial view of AstraZeneca's global R&D Centre, being completed on Cambridge Biomedical Campus. Picture: AstraZenecaAn aerial view of AstraZeneca's global R&D Centre, being completed on Cambridge Biomedical Campus. Picture: AstraZenecaAn aerial view of AstraZeneca’s global R&D Centre, being completed on Cambridge Biomedical Campus. Picture: AstraZeneca

David Spigel, chief scientific officer at the Sarah Cannon Research Institute, and investigator in the PACIFIC trial, said: ^Historically, only 15-30 per cent of these patients survived five years but these results show that with up to one year of treatment with Imfinzi, an estimated 43 per cent of patients are still alive at five years. Moreover, three quarters of these patients had also not progressed in that time. This is a momentous achievement at the five-year landmark in this curative-intent setting. ̄

And final results from the head-to-head ELEVATE-RR phase III trial of AstraZeneca¨s Calquence (acalabrutinib) demonstrated fewer events of atrial fibrillation when compared to ibrutinib in adults with previously treated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.

A four-year follow-up from the ELEVATE-TN phase III trial also showed strong benefits in terms of progression-free survival for Calquence as combination therapy or as monotherapy in previously untreated patients with CLL.

An aerial view of how AstraZeneca's South Plot building will look on Cambridge Biomedical Campus, near to its global R&D Centre. Picture: AstraZenecaAn aerial view of how AstraZeneca's South Plot building will look on Cambridge Biomedical Campus, near to its global R&D Centre. Picture: AstraZenecaAn aerial view of how AstraZeneca’s South Plot building will look on Cambridge Biomedical Campus, near to its global R&D Centre. Picture: AstraZeneca

And analysis of phase III trial data has showed anifrolumab was consistently associated with improvements in both skin rash and arthritis across three different disease measures each, compared to placebo, in patients with moderate to severe systemic lupus erythematosus.

Meanwhile, Tagrisso (osimertinib) has been approved in the EU for the adjuvant treatment of adult patients with early-stage EGFRm non-small cell lung cancer after complete tumour resection with curative intent. It follows positive results from a phase III trial in which it was shown to improve the disease-free survival in patients.

AstraZeneca has also announced the appointment of Aradhana Sarin as an executive director and chief financial officer, on the condition that the company¨s $39bn acquisition of Boston-based rare disease specialist Alexion Pharmaceuticals – expected in the third quarter – is completed.

Dr Sarin is currently executive vice-president, chief financial officer of Alexion, and will relocate from the US to the UK, where she will report to AstraZeneca CEO Pascal Soriot.

Marc Dunoyer, CFO of AstraZeneca, who is due to become CEO of Alexio if its acquisition by AstraZeneca is completed. Picture: AstraZeneca (47964557)Marc Dunoyer, CFO of AstraZeneca, who is due to become CEO of Alexio if its acquisition by AstraZeneca is completed. Picture: AstraZeneca (47964557)Marc Dunoyer, CFO of AstraZeneca, who is due to become CEO of Alexio if its acquisition by AstraZeneca is completed. Picture: AstraZeneca (47964557)

Dr Sarin will replace Marc Dunoyer, who will step down as CFO after more than seven years and retire from AstraZeneca¨s board to become CEO of Alexion and chief strategy officer at AstraZeneca, remaining part of its senior executive team

Read more

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Why AstraZeneca is acquiring rare disease specialist Alexion for $39bn

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Business News Life Science Paul Brackley

Hong Kong and Singapore will review plans for a long-awaited travel bubble early next month, and despite the city state making progress in taming a resurgence of Covid-19 cases, both governments say they will proceed cautiously towards launching the quarantine-free scheme.

Hong Kong commerce chief Edward Yau Tang-wah had been regularly in touch with his counterpart in the city state, a government spokesman said on Thursday, adding that both administrations were closely monitoring the Covid-19 situation.

^Both sides consider it to be prudent to keep the developments under review to ensure the epidemic situation is sufficiently stable before deciding in early July on the way forward for the air travel bubble, ̄ the spokesman said.

Do you have questions about the biggest topics and trends from around the world? Get the answers with SCMP Knowledge, our new platform of curated content with explainers, FAQs, analyses and infographics brought to you by our award-winning team.

In Hong Kong, 21.8 per cent of its 7.5 million residents had received at least one shot, while 15.3 per cent had taken both as of Thursday. Photo: Nora TamIn Hong Kong, 21.8 per cent of its 7.5 million residents had received at least one shot, while 15.3 per cent had taken both as of Thursday. Photo: Nora TamIn Hong Kong, 21.8 per cent of its 7.5 million residents had received at least one shot, while 15.3 per cent had taken both as of Thursday. Photo: Nora Tam

Singaporean Health Minister Ong Ye Kung said that even if the two sides met the criteria for starting the bubble, Singapore was still taking a cautious approach.

^We probably don¨t want to rush. It is important that in this state, embers [of infections] are still there, we want to be quite cautious, ̄ he told an afternoon press conference.

The scheme was slated to launch last November but was postponed after a surge in cases in Hong Kong. It was pushed back to May 26 and derailed again when the number of cases began to rise in Singapore, prompting a raft of tightened measures that are due to ease on Monday as the daily caseload comes under control.

The Hong Kong government said last month an announcement on the future of the travel bubble was expected by this weekend at the latest.

The spokesman said both administrations would review the target date for inaugural flights next month, taking into account the latest Covid-19 developments in Singapore, where the pandemic situation had been stabilising since early June.

Singaporean trade minister Gan Kim Yong admitted the launch would require some time, saying that if the vaccination rate climbed ^then this will give us greater confidence and greater flexibility in implementing air travel bubbles ̄.

As of Wednesday, a third of Singapore¨s population had been fully vaccinated, while 10.5 per cent have received only one shot. Authorities aim to fully vaccinate half of the 5.7 million population by August, and three-quarters by October.

In Hong Kong, 21.8 per cent of its 7.5 million residents had received at least one shot, while 15.3 per cent had taken both as of Thursday.

A source familiar with the situation said the two governments intended to resume the travel bubble sooner than later.

^The waiting time to relaunch the travel bubble won¨t be as long as the last time, which was almost half a year in between, ̄ the insider said.

Under the plan announced in April, travellers in either direction would have to undergo screening before departing and after arrival, although only Hong Kong would require its residents to be fully vaccinated to be eligible.

Those below 16 years of age, people advised against being inoculated for medical reasons, and residents using travel documents other than a Hong Kong passport for departure would be exempted from the vaccination rule.

But it was unclear whether those aged between 12 and 15 would have to follow the vaccine rule also after the government said they could receive inoculations starting on Monday.

The bubble scheme will be suspended for two weeks if the seven-day moving average of unlinked Covid-19 cases in either city exceeds five. As of Thursday, the figure for Hong Kong stood at 0.14, and at one for Singapore.

More from South China Morning Post:

Coronavirus: Hong Kong explores using finger pricks to draw blood for airport antibody tests

Hong Kong¨s quarantine hotels are almost full, as overseas students vie for rooms in summer rush

This article Hong Kong-Singapore travel bubble: early July review set for quarantine-free scheme amid coronavirus pandemic first appeared on South China Morning Post

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