Friday Five - The pharma week in review (9 October 2020)

Trump lauds antibody treatment as key to his COVID-19 recovery

To what extent President Trump's recent exposure to COVID-19 shapes the outcome of the forthcoming presidential election remains conjecture at this point, but speaking outside the Oval Office on Wednesday – 24 hours after being discharged from hospital – he appeared to pivot towards politicising an emerging class of new COVID-19 therapies based on neutralising antibodies.

President Trump can now point to first-hand experience of being treated with one of these therapies, specifically Regeneron Pharmaceuticals' antibody cocktail REGN-COV2, but his move to endorse this approach to treating COVID-19 (reportedly at no cost to the US public) also coincides with what appears to be the rapidly diminishing likelihood of a vaccine becoming available before election day.

On Tuesday, the FDA published briefing documents related to an upcoming advisory committee (AdCom) meeting on COVID-19 vaccines, as well as guidance for industry, in which it outlines anticipated stricter criteria that need to be met in order to support an emergency-use authorisation (EUA) request. The White House could theoretically overrule the agency and grant EUA status to one or more vaccines, a move described by some commentators as the 'nuclear option.'

Furthermore, the FDA received public support from Pfizer CEO Albert Bourla who decried the "amplified political rhetoric" surrounding the potential approval of an eventual COVID-19 vaccine. Via Twitter, Bourla noted that Pfizer would never discuss the FDA's guidelines on coronavirus vaccines with the White House as it could undermine the agency's independence and said "we believe FDA's independence is today more important than ever as public trust in COVID-19 vaccine development has been eroded by the politicisation of the process."

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And Eli Lilly provides more encouraging data

That said, continued momentum for investigational antibody-based COVID-19 therapies is encouraging, with this approach to treatment long considered by many to represent a potentially effective 'bridge' to when vaccines become widely available, potentially next year.

Whilst it is Regeneron's agent that has received Trump's direct endorsement this week (and likely a prominent position in the public's consciousness), it was new data released by Eli Lilly that added to the accumulation of clinical evidence suggesting that this approach to treatment could be effective.

Further interim results were released from the Phase II BLAZE-1 study, regarding use of LY-CoV555 in combination with the neutralising antibody LY-CoV016 in recently diagnosed patients with mild-to-moderate COVID-19.

Preliminary findings released last month from the LY-CoV555 monotherapy portion of BLAZE-1 demonstrated that the treatment reduced the rate of hospitalisations and emergency-room (ER) visits compared to placebo, while the middle dose level of 2800 mg achieved the trial's primary endpoint of change from baseline in viral load at day 11.

New data show that LY-CoV555 plus LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, met the primary endpoint by significantly reducing viral load at day 11, although the drugmaker indicated that most patients, including those on placebo, had near complete viral clearance by that time. However, the combination treatment reduced viral levels at earlier time points during the course of infection when higher viral loads are typically seen. Lilly added that an exploratory analysis showed that the proportion of patients with persistent high viral load at day seven for combination therapy was 3%, versus 20.8% for placebo.

The combination therapy also reduced the total symptom score from baseline to day 11, with improvements observed as early as three days after dosing, and was similar in magnitude and timing to improvements seen with LY-CoV555 monotherapy. Moreover, the rate of COVID-related hospitalisations and ER visits was lower for patients treated with combination therapy at 0.9%, compared to 5.8% for placebo, for a relative risk reduction of 84.5%. This was similar to observations for LY-CoV555 monotherapy as well, Lilly noted.

Lilly added on Wednesday that it has submitted a request to the FDA for EUA of LY-CoV555 monotherapy for higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. Regeneron has also requested EUA for its cocktail of two antibodies. In his speech on Wednesday, Trump suggested these requests would be quickly authorised.

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BMS is quickly back on the M&A trail

Bristol Myers Squibb announced this week it is to acquire the biotech company MyoKardia for $13.1 billion to expand its cardiovascular franchise.

Analysis – ViewPoints: Bristol Myers Squibb eyes CV stability with MyoKardia

The size of the deal caught some analysts by surprise given its relative proximity to completion of Bristol Myers Squibb's $74-billion acquisition of Celgene. However, in mavacamten (MyoKardia's most advanced asset), it has gained access to a heart disease treatment that appears to hold clear multi-billion dollar revenue potential and faces little in the way of direct competition over the next few years.

Our snap-poll of cardiologists appears to support this outlook for mavacamten, an investigational treatment for obstructive hypertrophic cardiomyopathy (HCM).

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Opdivo breaks new ground in neoadjuvant NSCLC

Bristol Myers Squibb also announced positive news by confirming that in the Phase III CheckMate-816 study its PD-1 inhibitor Opdivo plus chemotherapy met the primary endpoint of pathological complete response (pCR) versus chemotherapy alone as a neoadjuvant treatment for patients with resectable non-small-cell lung cancer.

The company noted that this is the first late-stage study to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy in this setting. Results showed that significantly more patients in the Opdivo group exhibited no evidence of cancer cells in their resected tissue, compared to those treated with chemotherapy alone. Full results will be presented at an upcoming medical meeting.

Bristol Myers Squibb can now claim four different successes in the treatment of earlier-stage cancers with Opdivo, including melanoma, oesophageal, bladder cancer and now NSCLC.

Returning the PD-1 inhibitor to growth after a slow-down in recent quarters could be critical in revving Bristol Myers Squibb back up and continued success in early-stage tumours should put the drugmaker on course to do just that.

More analysis here.

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How do oncologists perceive Eli Lily's monarchE data?

Moving cancer therapies that are effective in the metastatic setting into earlier-stage patients – in the hope of providing 'curative' effect – represents a broader strategy that is also occurring outside of the immunotherapy space.

Recently at the ESMO virtual congress, Eli Lilly presented positive data for its CDK4/6 inhibitor Verzenio in adjuvant-stage patients with hormone receptor-positive, HER2-negative breast cancer.

Oncologists we polled provided their feedback this week on what opportunity exists for Verzenio in this setting.

See Physician Views results: Verzenio impresses in early-stage breast cancer.

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