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Press Releases

Take a look at a selection of our recent media coverage:

Sotorasib and panitumumab effective in treatment-resistant metastatic colorectal cancer

21st September 2022

Sotorasib with panitumumab provided a 3-fold higher objective response rate than sotorasib mono-therapy in metastatic colorectal cancer

Sotorasib and panitumumab are a safe and effective combination for patients with chemo-refractory metastatic colorectal cancer according to the findings of a phase 1b trial presented at the European Society for Medical Oncology (ESMO) Annual Meeting in Paris, France.

Colorectal cancer (CRC) is the third most common cancer type worldwide and in 2020 there were an estimated 1.93 million cases and 916,000 deaths. However, among patients with metastatic disease, fewer than 20% survive beyond 5 years from their diagnosis. KRAS is a commonly mutated oncogene in CRC, and present in approximately 40% of all cases and sotorasib is a small molecule that selectively and irreversibly targets KRAS. Panitumumab is the first fully human monoclonal antibody directed against the epidermal growth factor receptor, leading to increased apoptosis, reduced proliferation of tumour cells and reduced angiogenesis with the result that tumour growth so that the development of metastases are prevented. Moreover, in patients with wild-type KRAS tumours, panitumumab is a useful option in combination with chemotherapy for the first- and second-line treatment of metastatic colorectal cancer.

In a previous single-arm, phase 2 trial, adult patients with KRAS mutated advanced colorectal cancer, mono-therapy with sotorasib led to a 9·7% overall response rate. In the current phase 1b trial, researched assessed the impact of adding panitumumab and eligible patients were those with refractory metastatic colorectal cancer on or after prior fluoropyrimidine, oxaliplatin, irinotecan and an anti-angiogenic agent. The researchers set the primary endpoint as safety but also examined the secondary endpoints of anti-tumour activity, progression-free survival, overall survival and pharmacokinetics.

Sotorasib objective response rate

While the trial is on-going, to date 40 patients (median age 57.5 years, 75% female) have been enrolled and received oral sotorasib 960 mg daily and panitumumab 6 mg/kg IV every 2 weeks. Overall, patients had a median of 2 prior lines of chemotherapy. In an associated press release by the manufacturer, Amgen, the median duration of treatment was described as 5.9 months with 25% of patients remaining on treatment at the time of data cut-off. With a median follow-up time of 8.8 months, the press release reports that median overall survival (OS) was not yet reached.

The confirmed objective response rate in the current trial was 30% (95% CI 16.6 – 46.5) and the disease control rate was 90% (95% CI 76.3 – 97.2). In addition, tumour shrinkage of any magnitude was observed in 87.5% of patients.

Treatment-related adverse events of any grade occurred in 92.5% of patients with grade 3 adverse events in 22.5% of patients although no adverse events were greater than grade 3 or led to treatment discontinuation.

The authors concluded that the combination therapy provided a 3-fold higher response than previously observed with sotorasib mono-therapy.

In the press release, David M. Reese, executive vice president of Research and Development at Amgen said ‘we are thrilled to see these CodeBreaK 101 results, which show that LUMAKRAS (sotorasib) plus Vectibix (panitumumab) achieved a 30% confirmed objective response rate in patients with KRAS G12C-mutated metastatic colorectal cancer. Treatment response rates can be as low as 2% in this patient population, and the current standard of care offers a median progression-free survival benefit of two months, so developing new treatment options is critically important for patients.’

Abstract
Sotorasib in combination with panitumumab in refractory KRAS G12C-mutated colorectal cancer: Safety and efficacy for phase Ib full expansion cohort

RSVpreF vaccine candidate effective against respiratory syncytial virus

31st August 2022

RSVpreF a vaccine candidate against respiratory syncytial virus showed a high level of efficacy in older adults with more severe infection

Pfizer’s vaccine candidate RSVpreF for respiratory syncytial virus (RSV) showed a high level of efficacy in older patients with more severe lower respiratory tract illness which was defined by three or more RSV-associated symptoms according to a press release from the company.

RSV is a major viral pathogen causing severe lung disease in the adult population, particularly among the elderly and which constitutes a substantial disease burden. The global number of hospital admissions for RSV-ARI in older adults has been estimated to be 336,000 leading to about 14,000 in-hospital deaths. Currently, there is no specific treatment for the virus apart from supportive care. RSV has two molecular subtypes A and B and RSVpreF is bivalent vaccine based on the crystal structure of pre-fusion F and which is a vital form of the viral fusion protein (F) that RSV uses to attack human cells. The vaccine itself contains two preF proteins which protect against the two main form of RSV, A and B which actually have multiple genotypes within each of them.

The press release provides top-line data from a phase 3 trial, RENOIR, designed to assess the efficacy, immunogenicity and safety of RSVpreF in adults. While RENOIR is not complete, the release describes how to date, the trial has enrolled approximately 37,000 participants and who were randomised to receive 120μg RSVpreF or placebo in a 1:1 ratio. Enrolment up to approximately 40,000 participants continues in the Southern Hemisphere to accumulate cases during their first season.

The information in the press release describes the findings of a pre-planned, interim analysis to assess protection against RSV-associated lower respiratory tract illness defined by two or more symptoms. The analysis determined a vaccine efficacy of 66.7% (96.66% CI: 28.8% – 85.8%). Based on this positive result, the manufacturer turned to the more severe disease primary endpoint defined by three or more symptoms and where the vaccine efficacy was 85.7% (96.66% CI: 32.0% – 98.7%). Moreover, an independent, external Data Monitoring Committee indicated the investigational vaccine was well-tolerated, with no safety concerns.

Commenting on these interim findings, Annaliesa Anderson, senior vice president and chief scientific officer, Vaccine Research and Development at Pfizer said ‘Scientists and researchers have worked to develop RSV vaccines with little success for over half a century. These findings are an important step in our effort to help protect against RSV disease.’

Pfizer is also investigating the efficacy and safety of RSVpreF in infants born to women vaccinated during pregnancy.

Bivalent Moderna vaccine likely to protect against Omicron sub-variants

26th June 2022

A bivalent Moderna vaccine was found to produce a potent neutralising antibody response against two Omicron sub-variants BA.4 and BA.5

According to a press release a bivalent Moderna vaccine is able to generate a large neutralising antibody response against two of the Omicron sub-variants, BA.4 and BA.5 and therefore likely to protect against these variants.

Both the BA.4 and BA.5 sub-variants of Omicron were detected in South Africa in January and February 2022, respectively. Moreover, there have recently been concerns raised over these two sub-variants especially after a study published in the New England Journal of Medicine, found that the sub-variants, substantially escaped neutralising antibodies induced by both vaccination and infection. The results of the study showed that among individuals who had received a third (i.e., booster) dose of BNT162b, compared with the response against the original COVID-19 isolate, the neutralising antibody titre was lower by a factor of 21 against BA.4 or BA.5. In other words, it appears highly likely that even among those who have been fully vaccinated, the BA.4 and BA.5 can lead to re-infection.

The bivalent Moderna vaccine has been studied in a phase 2 and phase 3 trial which has yet to be published. In the study, all participants who had previously received 2 or 3 doses of an approved COVID-19 vaccine were then given mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 4th dose.

Bivalent Moderna vaccine and Omicron sub-variants

According to the press release, for the COVID booster candidate, mRNA-1273.214, only one month after administration in previously boosted participants, a 50 µg booster dose elicited potent neutralising antibody responses against the Omicron sub-variants BA.4 and BA.5 in all participants. In fact, mRNA-1273.214 was able to increase the level of neutralising antibody titres against BA.4/BA.5 by 5.4-fold (95% CI 5.0 – 5.9) above baseline in all participants regardless of prior infection and by 6.3-fold (95% CI 5.7 – 6.9) in the subset of seronegative participants.

These results follow on from the data in a press release in early June 2022, in which Moderna announced that a booster dose with mRNA-1273.214 increased neutralising geometric mean titres (GMT) against the Omicron variant by approximately 8-fold above baseline levels. Moreover, a 50 μg booster dose of mRNA-1273.214 was well-tolerated in the 437 study participants and both the safety and reactogenicity profile of mRNA-1273.214 was similar to that of mRNA-1273 when these vaccines were administered as a second booster dose.

Based on these preliminary findings, Moderna is now working hard to complete all the necessary regulatory submissions in the coming weeks requesting to update the composition of the booster vaccine to mRNA-1273.214.

Paxlovid of no benefit to low risk patients with COVID-19

21st June 2022

Paxlovid is of no benefit to patients at a low risk of either being hospitalised or death after infection with COVID-19

According to the results of a press release from the manufacturer, Pfizer, paxlovid does not benefit patients who are either unvaccinated or vaccinated and who are deemed not at a high risk of severe complications such as hospitalisation or death if infected with COVID-19.

Paxlovid is a protease inhibitor antiviral therapy against COVID-19 and was developed to be taken orally, at the first sign of infection or at first awareness of an exposure. The early use of the drug could therefore help patients avoid severe illness and which might lead to hospitalisation or death, or avoid disease development following contact with an infected individual.

The June 2022 press release, follows on from the success of the results from an earlier trial, EPIC-HR, in which symptomatic, unvaccinated, non-hospitalised adults, at high risk for progression to severe COVID-19, were assigned in a 1:1 ratio to receive either 300 mg of nirmatrelivir plus 100 mg of ritonavir (i.e., Paxlovid) or placebo every 12 hours for 5 days.  The results of EPIC-HR were published in February 2022 and showed that treatment of symptomatic COVID-19 with paxlovid reduced the risk of progression to severe COVID-19 by 89% compared to placebo and without any major safety concerns. Based on these encouraging results, both the FDA and EMA approved the use of paxlovid for the treatment of mild-to-moderate COVID-19 in adults and children (12 years and older) who were deemed to be at high risk for progression to severe COVID-19, including hospitalisation or death.

With the success of their drug in high-risk patients, Pfizer proceeded with EPIC-SR, a phase 2/3 trial entitled, Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR). This time, the trial was designed to evaluate efficacy and safety in patients with a confirmed diagnosis of COVID-19 infection and who were deemed to be at standard risk (i.e., having a low risk for either hospitalisation or death). Enrolled participants were randomised 1:1, to receive paxlovid or matching placebo orally twice daily for five days.

Paxlovid in low-risk patients

The latest press release provides an updated analysis of the results from the EPIC-SR trial. The trial’s primary endpoint was self-reported, sustained alleviation of all (COVID-19) symptoms for four consecutive days. In an earlier press release from December 2021, Pfizer reported that primary endpoint in EPIC-SR was not met although this was based on an analysis of only 45% of the trial’s planned enrolment. Based on an updated analysis of 1,153 patients enrolled through December 2021, the current press release re-affirms, the results of the earlier, interim analysis. The data show that there was a non-significant 51% relative risk reduction in the primary outcome and in a sub-group analysis of 721 vaccinated adults who had at least one risk factor for progression to severe COVID-19, there was also a 57% non-significant relative risk reduction in hospitalisation or death.

However, not all of the current data is negative. When performing an additional analysis of secondary endpoint data, treatment with Paxlovid resulted in a nominally significant 62% decrease in COVID-19-related medical visits per day across all patients, relative to placebo (p = 0.0228).

Following these results, the press release reports that Pfizer has decided to cease enrolment into EPIC-SR due to low rate of hospitalisation or death in the standard-risk population but will continue to evaluate treatment in populations with high unmet need.

Paxlovid reduces hospitalisation and death in COVID-19

9th November 2021

Paxlovid, a novel COVID-19 oral anti-viral treatment, significantly reduced the risk of hospitalisation and death in patients with the virus.

Paxlovid given within three days of symptom onset to patients with COVID-19 significantly reduced the risk of hospitalisation and death. These were the results of an interim analysis posted by the manufacturer, Pfizer.

Paxlovid is a combination of Pfizer’s experimental drug (PF-00835231) and ritonavir. Both are protease inhibitors, a class of anti-viral drugs that have been used in the treatment of viral infections such as HIV and hepatitis C. COVID-19 produces a protease termed Mpro, which is vital to viral replication, and PF-00835231 been been found to be a potent inhibitor of Mpro. According to the manufacturer, co-administration of PF-00835231 and a low dose of ritonavir helps slow the metabolism of PF-07321332 so that it remains active for a longer period of time and at higher concentrations to help combat the virus.

Clinical study

In a clinical study, Paxlovid was used for the treatment of adults infected with COVID-19 but who, at the time of their illness, were not deemed sufficiently unwell to require hospitalisation but who were, however, considered to be at a higher risk of developing more severe illness. The study, Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR), is a randomised, 1:1, double-blind study, in which individuals received paxlovid or placebo orally every 12 hours for 5 days. The primary outcome of the study was the proportion of participants with COVID-19 related hospitalisation or death from any cause between days 1 and 28 after randomisation.

According to a pre-specified interim analysis based on 1219 participants, there was an 89% reduction in risk of COVID-19-related hospitalisation or death from any cause compared to placebo, in patients treated within three days of symptom onset. Overall, 3/389 (0.8%) who received paxlovid were hospitalised through to day 28 and there were no deaths but among 385 participants assigned to placebo, 27/395 (7.0%) were hospitalised and there were 7 deaths and this difference compared with Paxlovid was statistically significant (p < 0.0001).

Among patients treated within 5 days of symptom onset, 1.0% of those given Paxlovid were hospitalised through to day 28 (6/607) compared with 6.7% (41/612) of those given placebo (p < 0.0001). Moreover, to date, there have been no deaths were reported in patients receiving Paxlovid and 10 deaths in the placebo group.

According to the press release, based on a recommendation of the independent data monitoring committee and after consultation with the FDA, Pfizer will cease further enrolment and submit the data for the FDA’s emergency use authorisation (EUA) as soon as possible.

Further trials with Paxlovid are on-going and the company will release these results in due course.

Source. Pfizer press release, 5/11/2021