On September 13, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that the median Overall Survival (mOS) and Overall Response Rate (ORR) for patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy has now exceeded what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy (Press release, TME Pharma, SEP 13, 2023, View Source [SID1234635156]).

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After 17 months on study (median1), 67% of GLORIA expansion arm patients (4 of 6) are still alive. The median Overall Survival is expected to improve further as the remaining patients continue to receive treatment or follow-up care2.

The milestone in survival at 17 months is a crucial landmark since it means the NOX-A12-based therapy has surpassed the survival rates achieved in what TME Pharma believes to be all the relevant competitor studies conducted in the US or EU involving newly diagnosed, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients (see annex to this press release). In addition, the NOX‑A12-based therapy achieved this result despite having a more difficult population to treat since only patients with residual detectable tumor after surgery were included the NOX-A12 trial, while competing trials included patients with complete removal of detectable tumor.

OS: 17 months (and increasing) for NOX-A12 + bevacizumab vs 13.4-16.9 months
With Overall Survival (OS) of 67% at 17 months demonstrated by NOX-A12 combined with radiotherapy and bevacizumab, the median Overall Survival (mOS) will continue to improve since more than 50% of patients are still alive. This compares favorably to the 13.4 to 16.5 months mOS in the chemotherapy resistant population demonstrated by relevant competing therapies in clinical development and to the 16.9 months demonstrated by the Tumor Treating Fields device that was approved by the US Food and Drug Administration (FDA) for newly-diagnosed glioblastoma in 2015.

ORR: 83% for NOX-A12 + bevacizumab vs 3-7.8%
NOX-A12 combined with radiotherapy and bevacizumab demonstrated a strong Overall Response Rate (ORR) of 83%, which compares favorably with much lower percentages of 3%, 7% and 7.8% demonstrated by paxalisib, enzastaurin and nivolumab, respectively.

"This positive clinical update marks a significant step forward in our mission to transform the landscape of cancer treatment. The 17-month data and the exceptional survival rates in the GLORIA trial underscore the potential for NOX-A12 regimens to become the best available therapy for glioblastoma patients. We will need to confirm this potential in a larger, randomized trial," said Aram Mangasarian, CEO of TME Pharma. "We are immensely proud of the dedicated team of researchers and clinicians who have contributed to this remarkable achievement; they will provide detailed clinical updates at the upcoming Society for Neuro-Oncology (SNO) conference in November. We believe that continued strong performance of NOX-A12 clearly supports further development of the NOX-A12 + anti-VEGF combination with radiotherapy and improves NOX-A12’s profile for partnering and eligibility for accelerated regulatory pathways."

Annex: Competing benchmark therapies against chemotherapy resistant glioblastoma in development in the US or EU

Experimental Agent
(Company)

Surgical removal of
detectable tumor
(T=total; P=partial;
B=biopsy only)

Patient
number

Response
criteria

Overall
Response
Rate (ORR)

Median Overall
Survival (mOS)
in months

Status

Reference

NOX-A12 + Radiotherapy + bevacizumab (TME Pharma)

0% T; 100% P

6

RANO

83%

>17
(67% OS at 17m)

Ph 1/2 ongoing

TME Pharma Internal Data

Tumor Treating Fields (TTF) + Radiotherapy + Temozolomide (Novocure)

53% T; 34% P; 13% B

209

Macdonald

n.a.

16.9

Approved

Stupp R (2017), JAMA

Val-083 after Radiotherapy + Temozolomide chemotherapy) (Kintara)

information not provided

36

RANO

n.a.

16.5

Fast Track Designation granted; Ph 2/3 GBM AGILE ongoing

O’Brien (2021), Society for Neuro-Oncology Annual Meeting

Paxalisib + Radiotherapy (Kazia)

77% T; 17% P; 10% B

30

RANO

3%

15.7

Failed pre-defined criteria for GBM AGILE trial Ph 3

Wen P (2022); J Clin Oncol.

Enzastaurin + Radiotherapy (Denova)

43.9% T; 40.4% P; 15.8 B

57

Macdonald

7%

15

Fast Track Designation granted; Ph 3 ongoing

Wick W (2013), Neuro Oncol.

Temozolomide chemotherapy + Radiotherapy + bevacizumab (Roche)

63% T; 34% P; 3% B #

215

Macdonald

n.a.

14.3

Failed in Ph 3

Gilbert MR (2014), NEJM

Nivolumab anti-PD-1 immunotherapy + Radiotherapy (BMS)

54% T; 46% P

280

RANO

7.8%

13.4

Failed in Ph 3

Omuro A (2022); Neuro Oncol.

Temozolomide chemotherapy + Radiotherapy

information not provided

60

n.a.

n.a.

12.7

Approved
(current standard of care)

Hegi ME (2005) NEJM

# For this study resection status applies to the total patient population (MGMT methylated + unmethylated)