Friday Five - The pharma week in review (25 September 2020)

Ref: Friday Five Desk

ESMO – The headliners

This year's annual meeting of the European Society of Medical Oncology (ESMO) took place virtually last weekend and a number of potentially practice-changing presentations stole the headlines.

The combination of Bristol Myers Squibb's Opdivo and Exelixis' Cabometyx looks set to emerge as a new first-line treatment for metastatic renal cell carcinoma, for example. Elsewhere, new data suggest that some early-stage, hormone receptor-positive, HER2-negative breast cancer patients could have their risk of disease recurrence lowered by adjuvant treatment with Eli Lilly's Verzenio.

Immunotherapy (specifically Opdivo or Merck & Co.'s competing PD-1 inhibitor Keytruda) looks poised to become a new first-line standard of care for metastatic gastric cancer when used in combination with chemotherapy, while progress in the search for new ways of treating triple-negative breast cancer (TNBC) continues to gain momentum, with Roche's PD-L1 inhibitor Tecentriq showing promise in neo-adjuvant patients.

Analysis

ESMO ViewPoints: A case is made for Opdivo/Cabometyx in RCC

KOL Views Results: Leading oncologist says QOL data from CheckMate-9ER may give Opdivo/Cabometyx edge in 1L RCC

ESMO ViewPoints: Verzenio outmanoeuvres Ibrance in adjuvant breast cancer

KOL Views Results: Leading oncologist says Verzenio is a CDK4/6 winner but Ibrance, Kisqali remain threats in adjuvant breast cancer

ESMO ViewPoints: Bristol Myers Squibb, Merck & Co. battle in gastric cancer

______________

ESMO – What you may have missed

Beyond the headline presentations there was a wealth of other data presented, in some cases enhancing the status of existing standards of care and in others providing an early glimpse at promising new treatment options.

New results were unveiled that could accelerate future adoption of AstraZeneca's Tagrisso and Imfinzi franchises, in early-stage EGFR mutation-positive non-small-cell lung cancer (NSCLC) and stage III NSCLC, respectively.

Tagrisso could also face a new competitor in the form of Johnson & Johnson's amivantamab, a bi-specific antibody that targets EGFR and cMET receptors. Combined with Johnson & Johnson's novel EGFR inhibitor lazertinib, amivantamab will be pitched had-to-head against Tagrisso in a Phase III study.

Other ESMO analysis

ESMO ViewPoints: Great is not quite good enough for Libtayo in NSCLC

ESMO ViewPoints: Merck & Co.’s TIGIT data reinforce Roche’s uncertain position

ESMO ViewPoints: Alkermes long-awaited glimpse of next-gen IL-2 data

ESMO ViewPoints: Amgen’s KRAS update looks good for regulators, and middling for investors

______________

Gilead's new drug impresses

Focus on new data presented for Immunomedics' antibody-drug conjugate (ADC) Trodelvy in third-line TNBC sharpened in the days leading up to ESMO, after the biotech entered an agreement to be acquired by Gilead Sciences for $21 billion earlier this month.

The data did not disappoint and improves the odds of Trodelvy producing compelling results in earlier-stage TNBC. Scrutiny over the price Gilead paid to acquire Immunomedics appears to be receding already.

See ESMO ViewPoints: Immunomedics makes its case for TNBC expansion and Gilead beat three other companies in pursuit of Immunomedics

______________

COVID-19 round-up

Johnson & Johnson has confirmed that a Phase III study of its COVID-19 vaccine candidate has started following positive interim data from a Phase I/IIa trial.

The ENSEMBLE study will enrol up to 60,000 volunteers and will evaluate the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19. Results are expected by year end or early in 2021. 

Fujifilm announced Wednesday that a Phase III study of Avigan (favipiravir) in COVID-19 patients with non-severe pneumonia met its primary endpoints. The trial, which compared Avigan to placebo, both in addition to standard treatment, was conducted in Japan and began in March.

The study's primary efficacy endpoint is time to negative conversion of detectable SARS-CoV-2 viral RNA in RT-PCR assays, and to alleviation of symptoms, including body temperature, oxygen saturation and chest images. Results from an analysis of 156 individuals showed that participants randomised to receive Avigan had a significantly shorter time to resolution, with those given the antiviral improving after a median of 11.9 days compared to 14.7 days for placebo.

______________

Have hopes for anti-Tau in Alzheimer's been dented?

The collective industry effort to develop condition-modifying treatments for Alzheimer's disease appeared to take an unfortunately familiar blow on Wednesday when partners Roche and AC Immune announced that the experimental anti-Tau monoclonal antibody semorinemab failed to slow cognitive and functional decline in patients with early Alzheimer's disease in the Phase II TAURIEL study, which missed both its primary and two secondary endpoints. 

AC Immune said analyses of additional data are under way, including biomarkers such as Tau-PET, adding that the TAURIEL results will be presented at a future medical meeting. Andrea Pfeifer, chief executive at AC Immune, described the results as "surprising and disappointing, given what we as a field know about Tau and its strong spatiotemporal correlation with both symptoms and pathology in Alzheimer's disease." However, Pfeifer remarked "we believe the full data analysis of this first-of-its-kind study will yield information about this promising target that will advance our understanding and inform future efforts." Meanwhile, the Phase II LAURIET trial of semorinemab in patients with moderate Alzheimer's disease remains ongoing.

Analysis – ViewPoints: Homerun off the table for Roche, AC Immune’s anti-tau mAb